Sleep Position Trainer. Information for physicians

Transcription

1 Sleep Position Trainer Information for physicians

2 Sleep Position Trainer Information for physicians 1. Product information 2. Scientific background 3. Abstracts

3 Sleep Position Trainer The best treatment for Positional OSAS

4 Innovation distinguishes between a leader and a follower. - Steve Jobs

5 Positional Therapy for (P)OSAS Positional Obstructive Sleep Apnea Syndrome (POSAS) is caused by gravitational forces on the tongue, soft palate and throat, resulting in repeated collapse of the airway during sleep, reducing oxygen saturation in the blood. The severity varies per patient and determines what kind of treatment the patient requires. Supine POSAS = AHI supine > 2x AHI non-supine POSAS is defined as OSAS where the Apnea Hypopnea Index (AHI) level is at least twice as high during supine sleep compared to the AHI during sleep in all other positions. Positional Therapy with the SPT is a comfortable alternative Prevalence of POSAS patients worldwide (estimated) for your patients 80 73,4 Mio 56% 6.4% 15,7 Mio 6% 6,7 Mio of mild and moderate OSAS patients have POSAS (Richard, 2006) (X1 million) Mild AHI 5-15 Moderate AHI Severe AHI 30= (CIA, 2014; Eijsvogel, 2012; Leong, 2013; Mador, 2005) of the population is suffering from OSAS (Eijsvogel, 2012) 30% have a higher supine AHI, but not twice as high (Richard, 2006) Patient selection: For successful treatment with Positional Therapy, the following conditions should apply to your patient. Mild and moderate OSAS (AHI 5-30) Positional OSAS: AHI supine > 2x AHI non-supine Sleeping within 10-90% of the night supine Able to sleep in non-supine position (eg. no shoulder or specific back problems)

6 Sleep Position Trainer The best treatment for Positional OSAS How it works The Sleep Position Trainer (SPT) measures the sleep behavior of the patient continuously. Once the patient turns in to the supine position, this normally happens during lighter sleeping stages, the SPT gives a gentle vibration. This reminds the patient to change their sleeping position, without disrupting their natural sleep architecture. The SPT is worn in a comfortable torso strap around the upper body. In addition, the SPT comes with software to analyze the progress of the treatment. I used the SPT myself for several weeks, and found the device quite comfortable, the SPT did not negatively affect my sleep at all. - David P. White, MD Clinical Professor of Medicine, Harvard Medical School. Soft torso strap Adjustable to the body Multiple sizes Actual size (72 mm) Lightweight Freedom to move Go-to-sleep & pause mode Sleep data read-out Rechargeable battery via USB SPT Comfort Program The SPT Comfort Program helps the patient get used to sleep in a non-supine position by gradually reducing the amount of supine sleep. The first two nights the SPT only measures the sleep behavior. From the third to the tenth night, the SPT slowly builds up the amount of feedback. This improves the acceptance of the SPT by the patient. Innovative features increase comfort of the SPT Automatic personalized feedback program The SPT automatically adjusts the vibrations to the need of the patient. The feedback program contains eight different vibration levels and five different vibration patterns. Night Feedback Analysis Build-up Position training High compliance Easy to maintain Does not disrupt sleep Limited side effects Reversible Combination therapy possible 0 % 100 %

7 I noticed a clear difference: I feel more energetic during daytime, I don t fall asleep on the couch and feel less tired while driving. - J. Homan, patient, after sleeping with the SPT for one month.

8 Proven effective with high compliance 92.7% The SPT does not affect nor disrupt the sleep architecture of the patient (Eijsvogel, 2013; Van Maanen, 2013) compliant to the SPT (Van Maanen, 2013) Highest mean disease alleviation (MDA) A measure of the overall therapeutic effectiveness SPT MRA CPAP TBT 51.1% 50.0% 48.6% 70.5% MDA 70 (Eijsvogel, 2013; Vanderveken, 2013; Grote, 2000) 80 48% patients cured (AHI < 5) (Van Maanen, 2013) 90.5% reduction in supine sleep (Van Maanen, 2014) 68.8% reduction on total AHI (Van Maanen, 2013) With the SPT the supine sleep is reduced to an average of 3% supine sleep, this effect is maintained after six months (Van Maanen, 2014) Effective and well-tolerated treatment for POSAS patients The SPT has been clinically tested in over 35,000 nights The SPT makes other therapies more effective 52.1% improved reduction of AHI when SPT is added to a Mandibular Repositioning Appliance (MRA) treatment (Dieltjens, 2012)

9 Read out patient data with SPT Connect software The SPT measures the sleep behavior of the patient continuously and stores the information in its internal memory. Patients can analyze the comprehensive overview of the sleep data gathered by the SPT with the use of our SPT Connect software for Windows. Physicians can easily generate sleep reports with the separate supplied software for specialists. These reports provide an overview of the effectiveness, compliance and overall progress of the treatment. Detailed overview of one night Numbers tell the tale Analyze your patient s treatment progress with our SPT Connect software Overview of one week

10 The SPT has potential to become a game changer. - Prof. dr. N. de Vries, a.o. member of guideline committees on obstructive sleep apnea. Reference: Central Intelligence Agency, CIA. The World Factbook - Population, Age structure. On Aug 20th library/publications/the-world-factbook/geos/xx.html Dieltjens M, Vroegop AV, Verbruggen A, Willemen M, Verbraecken JA, van de Heyning PH, Braem MJ, de Vries N, Vanderveken OM. Effect of Sleep Position Trainer and Mandibular Advancement Devices on residual Positional Sleep Apnea under MAD therapy: a randomized clinical trial. Prevention and Research 2(3-Suppl. II) Oral Presentation, American Academy of Dental Sleep Medicine (AADSM), Baltimore, USA Eijsvogel M. Screening for OSAS in Philips employees. Oral Presentation, Nederlandse Vereniging voor Slaap-waak onderzoek (NSWO), Groningen, the Netherlands Eijsvogel M, de Jongh F, Brusse-Keizer M. Sleep Position Trainer vs. Tennis Ball Technique in positional OSA [Abstract]. Barcelona: European Respiratory Society Annual Congress 2013;42(57):3586. Grote L, Hedner J, Grunstein R, Kraiczi H. Therapy with ncpap: incomplete elimination of Sleep Related Breathing Disorder. The European respiratory journal 2000;16: Leong WB, Arora T, Jenkinson D, Thomas A, Punamiya V, Banerjee D, Taheri S. The prevalence and severity of obstructive sleep apnea in severe obesity: the impact of ethnicity. J. Clin Sleep Med 2013;9(9): Mador MJ, Kufel TJ, Magalang UJ. Prevalence of positional sleep apnea in patients undergoing polysomnography. Chest 2005 (128): Richard W, Kox D, den Herder C, Laman M, van Tinteren H, de Vries N. The role of sleeping position in obstructive sleep apnea. Eur Arch Otorhinolaryngol 2006;263: Vanderveken OM, Dieltjens M, Wouters K, de Backer WA, van de Heyning PH, Braem MJ. Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Thorax 2013;68:91-6. Van Maanen JP, Meester KA, Dun LN, Koutsourelakis I, Witte BI, Laman DM, Hilgevoord AA, de Vries N. The sleep position trainer: a new treatment for positional obstructive sleep apnoea. Sleep & breathing = Schlaf & Atmung 2013;17: Van Maanen JP, de Vries N. Long-term effectiveness and compliance of positional therapy with the sleep position trainer in the treatment of positional obstructive sleep apnea syndrome. Sleep 2014;37:

11 SPT Experience Sleep Position Trainer trial device For Positional OSAS patients Provide your patient with the opportunity to test the Sleep Position Trainer (SPT). Determine if the SPT is a suitable treatment option for your patient by using the SPT Experience. Night Analysis Build-up Position training Feedback 0 % 100 % The SPT Experience is a device similar to the normal SPT with the exception that it will stop working after 28 nights. A SPT Experience report can be generated by a physician to analyze the sleep data of the patient. Based on the results the physician and the patient can conclude if the SPT is a suitable treatment option for the patient. Prepare for next use Once the SPT Experience trial period is finished, the device can be reset and prepared for the next patient via the SPT Connect Specialist software. Sleep Position Trainer The SPT measures the sleep behavior of the patient continuously. Once the patient turns into the supine position the SPT gives a gentle vibration. This reminds the patient to change their sleeping position, without disrupting their natural sleeping architecture. The device is worn in a comfortable torso strap around the upper body.

12 August 2014 scientific background & evidence on the clinical effectiveness of Postional Therapy with the Sleep Position Trainer in Position-dependent Obstructive Sleep Apnea Syndrome patients Abstract Although Positional Therapy (PT) is an effective treatment modality for Positional Obstructive Sleep Apnea Syndrome (POSAS) patients, it has severe discomfort issues and hampering compliance rates. Therefore it has not been applied to its full clinical potential. The Sleep Position Trainer (SPT) is an innovative technique for PT, which has been designed to encounter the issues of conventional methods for PT. In several clinical studies, this SPT was found to be very effective in treating POSAS patients through decreasing the Apnea-Hypopnea Index (AHI) (from to ) and the supine sleep time (from 49.9%-34% to 5%-0%). Moreover, high compliance rates on short and long term were found (71% 93%) in different cohorts throughout 1 to 6 months of treatment (compliance definition: 4 hours per night, 5-7 days per week). Researchers conclude that the SPT has acceptable and high compliance rates, and is a well-tolerated and non-disruptive device for the treatment of POSAS patients. PT is one of the treatment options for Obstructive Sleep Apnea Syndrome (OSAS) patients to prevent them from sleeping in their worst position, which is often supine. 1 PT is especially targeted at POSAS patients, who have at least twice as much obstructive events in supine position than in other positions. 2,3 A steady 56% of patients with OSAS was found to have POSAS. 4,5 The number of events per hour of these patients, measured as the AHI, can significantly be reduced by applying PT. Hence, PT is an effective therapy modality for POSAS patients, as proven in different studies. 2,3,6 However, due to significant discomfort and noncompliance issues, the existing methods were not applied in daily medical practice, while PT has a high potential for effectively treating POSAS patients. 6 The NightBalance SPT type Pyxis has been designed to encounter the issues of the conventional methods for PT. This paper describes how the SPT tackles the problems of the conventional techniques for PT. Furthermore, it illustrates how this leads to improved effectiveness results and increased long-term compliance rates in various scientific studies on the SPT. 1. SPT s approach towards patients difficulties with PT PT has proven to be effective in treating POSAS, but lacks compliance Various techniques for PT are described in scientific literature, which focus on the preventing the supine position such as Tennis Ball Techniques (TBT), positional alarms, verbal instructions, vests, shark fins or special pillows. 6 The studies report positive results on the AHI, and have been incorporated in several medical protocols globally. 7-9 Despite their effectiveness, discomfort and consequent disruption of sleep architecture have been responsible for poor compliance rates and subsequent disappointing long-term results of these interventions The compliance rates of patients vary between twenty and forty percent for the different TBT methods. 13,17,18 Therefore, the prescription of TBT has not sufficiently found its way in clinical practise. The SPT: a new solution to improve effectiveness and compliance A new technique for PT has been developed, the SPT: a vibratory device that not only monitors the sleep position of patients, but also actively corrects the sleep posture. When wearing the device, the adoption of the supine sleep position triggers a vibration and stimulates the patient to adopt a new sleep position, without significantly reducing total sleep time or disrupting sleep. 19 The SPT targets many of TBT s issues as reported in the medical literature: 6 passive TBT s limitation: Fast adaptation One can quickly adapt to the TBT, decreasing its effectiveness. The human somatosensory system adapts naturally to pressure stimuli that are applied constantly to the skin. The adaptation time is rather short and depends on pressure and size of the stimulant; the lower the pressure and the larger the size of the stimulant, the shorter the adaptation time to the stimulus. 20 active spt s solution: No adaptation through vibration a vibrating stimulus with fast pressure changes forms an effective stimulus. 20 The SPT uses active vibrotactile stimuli, contrarily to TBT s passive pressure. tbt s limitation: Cognitive habituation Continuous stimulation during sleep is hampered by cognitive habituation. 21,22 For TBT specifically, this means that when one sleeps on top of the object, the person is able to get used to this stimulation during sleep. Hence, the stimulation can be ignored, resulting in poor TBT effectiveness spt s solution: Changing vibration pattern reduces habituation studies showed that varying intervals between stimuli helps to avoid habituation. 21,22 The SPT uses such patterns in order to be able to give vibrational feedback to its user effectively throughout the entire night. off on tbt s limitation: Not taking individual characteristics into account the perceived tactile sensitivity depends on individual subject variances. A study overview based on 20 papers shows several personal characteristics that influence the vibro-tactile threshold, like for example BMI, age, alcohol intake, skin temperature, and gender. 23 TBT does not allow individual adaption to its user. automatic SPT s solution: Programmed to individual characteristics the SPT adapts automatically its vibration strength and patterns based on the user s reaction time after the vibrational stimulus was given.

13 scientific background & evidence august 2014 TBT s discomfort: Full movement restriction the bulky object, which characterizes the TBT, hampers its user to switch sides during sleep, which can cause a significant reduction in comfort and quality of sleep or can even cause the patient to wake up. 16,21,22, SPT s solution: 360 degrees freedom of movement the SPT is flat and allows rolling over the back, enabling natural position changes. TBT s discomfort: 20% sleeps on top of bulky TBT Different scientific studies report that 20 to 30% patients still sleep in supine position despite sleeping with a bulky mass strapped to their back. On average, TBT users sleep upto thirty minutes per night on top of the object, causing significant discomfort and backaches. 16,21,22,24 spt s solution: The SPT is flat, and is worn on the front the SPT is an ergonomic device and does not have a bulky object in order to prevent users to adapt the supine sleep position. start tbt s discomfort: Trouble falling asleep Falling asleep while wearing the TBT does not allow a user to do so in its preferred and most comfortable sleep. Research shows that another reason for stopping the therapy with TBT is due to not being able to fall asleep comfortably in the preferred position. 16,21,22,24 30 min SPT s solution: Relaxed sleep onset with a sleep-in period the SPT has a sleep-in period, which provides its user with the possibility to fall asleep comfortably in every desired sleep position. TBT s discomfort: Instant response required since TBT is a static modality, many patients have difficulty to directly accustom to wearing a bulky mass on their backs and not to sleep in supine position. They therefore may abort the treatment prematurely. 16,21,22,24 training SsPT s solution: Gradual training program the SPT has an integrated feedback program, which gradually trains patients to sleep in supine position. TBT s discomfort: Continuous use required With the TBT, there is no option to shortly lay in supine position. Being tempted to shortly take off the TBT, users can be discouraged to continue the therapy and put it back on. spt s solution: Pause mode enables short breaks the SPT has a built-in pause mode to increase continuous use during the full night, even after short nightly breaks. TBT s limitation: No monitoring Currently, researchers and clinicians are increasingly aware of the importance of compliance in therapies. 25,26 However, TBT devices in general have poor monitoring possibilities. spt s solution: Monitoring and data read out the SPT enables compliance monitoring for both patients and tbt s limitation: No guidance according to research, CPAP adherence can significantly be improved through adequate training and guidance. 27 However, this does not necessarily need to be in person. 28 The TBT, generally not being a medical device, does not have any procedures or guidance that will help patients with their therapy management or spt s solution: Online support the SPT has automatic monitoring options with individual guidance in order to stimulate compliance. Conclusion As indicated in research on PT and sleep architecture, TBT suffers from various discomfort issues, although it has been proven effective. With its current approach, the SPT anticipates on most of the problems. It was designed to be more comfortable and hence, designed to improve compliance rates significantly. 2. Clinical evidence of SPT s effectiveness and compliance To measure the effectiveness of the SPT as a method for PT in position-dependent sleep apnea patients and to investigate to what extent the SPT fulfils its aims on improving compliance through comfort and monitoring, several clinical trials have been executed in the past years. Efficacy: Reduction of the AHI From 2006 onwards, the effectiveness of the SPT, in terms of reduction of AHI, has been studied. For the thirty patients, who participated in this one-night observational cohort study, the mean AHI dropped from 27.7 ± 2.4 to 12.8 ± 2.2 when testing a preliminary SPT. Furthermore, for seven patients the AHI decreased to a level below the AHI threshold of five and were cured when using the device. 29 Thereafter, results improved as the same group studied the reduction of the AHI in 31 mild to moderate POSAS patients, when applying the final prototype of the SPT. Their median AHI decreased from 16.4 [ ] to 5.2 [ ] (p<0.001) after one month of treatment. For fifteen patients the AHI dropped below the AHI threshold of five. 19 In an one-month Randomized Controlled Trail (RCT), in which the SPT was compared to TBT, the average total AHI dropped from 11.4 to 3.9 and 13.2 to 5.8 in respectively 29 patients using the SPT and 26 TBT patients. Besides that, no differences between both modalities were found in the scores of the QSQ and the ESS. On the other hand, a significant difference was found in the VAS scores on the self-rated therapeutic effectiveness; for SPT it was 74.5 and for TBT 55.2 (p=0.02). 30 Preliminary RCT results from patients with residual POSAS, while being under Mandibular Advancement Device (MAD) treatment, show

14 scientific background & evidence august 2014 significant added value for PT through SPT for the first 20 patients that completed the full study protocol. The baseline AHI diminished from 23 ± 11 to 6 ± 3 when applying a combination therapy of MAD and SPT in these patients. Besides that, MAD and SPT were both find to be significantly effective in reducing the AHI singularly, when compared to the baseline AHI; to 12 ± 5 for MAD and 12 ± 8 for SPT. 31 In clinical research, the SPT shows to decrease the AHI significantly in mild to moderate POSAS patients. Furthermore, it was found to cure particular POSAS patients after the AHI fell below five through the use of SPT, and is an effective option for more severe patients in combination with other treatment modalities. Compliance 100% 80% 60% 40% 20% 0% Figure 2. 11/26 TBT 22/29 SPT Effectiveness: Reduction of supine sleep time As a primary outcome measure for PT, the reduction of sleep time in supine position has been studied for the SPT in several trials, relative the total sleep time. In first study with the final SPT prototype, the median percentage of supine sleeping time declined from 49.9% [ ] to 0.0% [ ] (p<0.001) in 31 mild to moderate POSAS patients after one month of treatment. 19 Furthermore, in the RCT comparing TBT and SPT, the average sleeping time in supine position decreased significantly to 0.0 for both groups after onemonth therapy. 30 Likewise, in the RCT on MAD-residual POSAS, the percentage of supine sleep time decreased significantly from 34% ± 26 to 1% ± 4 for the combination therapy with both MAD and SPT. Furthermore, this percentage significantly diminished for the SPT singularly (to 2% ± 7), when analyzing the preliminarily RCT results in 20 patients. 31 In 2012, a long-term multicenter study has been performed in the Netherlands, in which a cohort of 106 patients completed the full study protocol. 32 Besides subjects compliance, the reduction of the percentage of sleep time in supine position over six months of treatment was one of the main outcomes. Figure 1 illustrates that the median percentage of supine sleep time, decreased rapidly during SPT s training phase (day 3 to 9) to near total avoidance of supine sleep. This decrease was maintained during the 6 months of treatment (21% at baseline vs. 3% at 6 months). 32 In conclusion, the SPT is able to significantly reduce the time per night slept in supine position of POSAS patients and, hence, directly affects the positional aspects of their OSAS. In this way, the SPT effectively prevents its users from sleeping in supine position. Getting effectiveness to work: high short-term and long-term compliance The most effective therapy options are only truly effective when used. 25,26 Compliance, therefore, is key to successful treatment and has been the focus of most studies with the SPT. In the RCT comparing SPT and TBT, compliance, defined as the usage of more than 4 hours/night for more than 5 days/week, was Compliance 100% Figure 3. 80% 60% 40% 20% 0% SPT 22/29 TBT 11/26 Days found to be 76% for SPT compared to 42% for TBT (p=0.01) over one month. For both therapies drop-outs were registered: 7% in SPT and 28% in TBT (see figure 2,3). 30 Furthermore, in the cohort of 31 POSAS patients with the final SPT prototype, the compliance of patients was 92.7% over one-month treatment, defined as the use of the SPT for at least 4 hours per night for seven nights per week. 19 When studying compliance on the long term and using the same definition, the compliance over six months was found to be 64.4% in the 106 patients that participated in the Dutch multicenter cohort study. 32 When applying a definition of 4 hours of use for at least 5 nights per week, the compliance was 71.2% in this six-month period. Due to the high number of investigational sites (19 hospitals) and several IT bugs in tracking safety nets, a relative high number of patients were lost in follow-up. For all patients that were lost in follow up, the worst-case scenario has been assumed for further calculations; zero compliance. This worst-case assumption brings the compliance to 64.4% %. For the 53 subjects, for which full records were collected, a compliance rate of 100% was found over 6 months, when applying a definition of at least 4 hours of use during a minimum of 7 nights per week. 32 Figure 1. Conclusion The compliance of POSAS patients with the SPT is considerably higher than for TBT. Moreover, the results on short and longterm compliance indicate high rates for SPT over a period of six months time.

15 scientific background & evidence august SPT s clinical results: researchers conclude The results of these studies show that the effectiveness of POSAS treatment with the SPT is equal to other methods for PT when comparing the reduction of AHI and sleep time in supine position. 19,30,31 Other methods for PT show compliance rates between %. 6 However, the compliance of POSAS patients with the SPT appears to be substantially higher than other techniques for PT and over different periods over time. For the SPT, compliance rates vary between % from long-term to short-term, respectively. 19,29,30,31,32 The researchers state that both methods for PT (TBT and SPT) are effective treatment options for POSAS patients. 30 However, only the SPT has an acceptable compliance rate after one-month therapy. 30 Moreover, other scientists conclude that therapy with the SPT is a well-tolerated treatment for patients with POSAS with a high compliance, which improves sleep-related quality of life and decreases subjective sleepiness without interrupting the sleep architecture. 19 The SPT is an innovative and effective medical device for the treatment of POSAS. This device can be used in approximately half of all OSAS patients, hence one to two percent of the total Western population. The effectiveness of therapy with the SPT is comparable to the effectiveness of other methods for PT. Contrarily, the compliance rates of the SPT are sufficient for effective treatment of POSAS and acceptable for application of the SPT in daily medical practice, when compared to other PT methods. The device is non-disruptive in terms of sleep quality and is welltolerated. In conclusion, the SPT fulfills its aim to be an effective and comfortable method for PT for the treatment of POSAS patients with high compliance rates through tackling the TBT issues. Moreover, the recent results from a longitudinal study indicate that the SPT also has substantially higher compliance rates on the long term. 32 Therefore, the SPT has met its last goal on high long-term compliance as well. With the SPT, NightBalance is able to provide a new and effective therapy for POSAS patients worldwide. Literature 1. American Academy of Sleep Medicine The international classification of sleep disorders, 2nd ed: diagnostic and coding manual. Westchester, IL: American Academy of Sleep Medicine. 2. Mador, M.J., T.J. Kufel, U.J. Magalang Prevalence of positional sleep apnea in patients undergoing polysomnography. Chest 2005 (128): Permut, I., M. Diaz-Abad, W. Chatila, J. Crocetti, J. Gaughan, G. Alonzo, S. Krachman Comparison of positional therapy to CPAP in patients with Positional obstructive sleep apnea. Journal of Clinical Sleep Medicine 6 (3): Oksenberg, A., E. Arons, S. Greenberg-Dotan, K. Nasser, H. Radwan The significance of body posture on breathing abnormalities during sleep: data analysis of 2077 obstructive sleep apnea patients. Harefuah 148: Richard, W., D. Kox, C. den Herder, M. Laman, H. van Tinteren, N. de Vries The role of sleeping position in obstructive sleep apnea. European Archives of Oto-rhino-laryngology 263: Ravesloot, M.J., J.P. van Maanen, L.N. Dun & N. de Vries The undervalued potential of positional therapy in position-dependent snoring and obstructive sleep apnea-a review of the literature. 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Hultcrantz Positioner- a method for preventing sleep apnea. Acta Oto-Laryngologica 127: Cartwright, R.D., S. Lloyd, J. Lilie, H. Kravtiz Sleep position training as treatment for sleep apnea syndrome: a preliminary study. Sleep 8: Cartwright, R.D., R. Ristanovic, F. Diaz, D. Caldarelli, G. Alder A comparative study of treatments for positional sleep apnea. Sleep 14: Bignold, J.J., G. Deans-Costi, M.R. Goldsworthy, C.A. Robertson, D. McEvoy, P.G. Catcheside, J.D. Mercer Poor long-term patient compliance with the tennis ball technique for treating positional obstructive sleep apnea. Journal of Clinical Sleep Medicine 5: Bignold, J.J., J.D. Mercer, N.A. Antic, R.D. McEvoy, P.G. Catcheside Accurate position monitoring and improved supine-dependent obstructive sleep apnea with a new position recording and supine avoidance device. Journal of Clinical Sleep Medicine 7: Van Maanen, J.P., K.A. Meester, L.N. Dun, I. Koutsourelakis, B.I. Witte, D.M. Laman, A.A. Hilgevoord, N. de Vries The Sleep Position Trainer: a new treatment for positional obstructive sleep apnoea. Sleep and Breathing 17(2): Krantz, J.H Skin Senses. In: Experiencing Sensation and Perception. Hanover: Hanover College. 21. Fridel, K.W Adherence and effectiveness of positional therapy for obstructive sleep apnea syndrome. Tucson: University of Arizona. 22. Bignold, J.J Poor long-term compliance with the tennis ball technique for treating positional obstructive sleep apnea. Journal of Clinical Medicine 5: Gandhi, M.S., R. Sesek, R. Tuckett, S.J. Morris Bamberg Progress in Vibrotactile Threshold Evaluation: A Review. Journal of Hand Therapy 24(3): Oksenberg, A., D.S. Silverberg, D. Offenbach Positional therapy for obstructive sleep apnea patients: a 6-month follow-up study. The Laryngoscope 16: Ravesloot, M.J.L., N. de Vries Reliable calculation of the efficacy of non-surgical and surgical treatment of obstructive sleep apnea revisited. Sleep 34: Kribbs, N.B., A.I. Pack, L.R. Kline, P.L. Smith, A.R. Schwartz, N.M. Schubert, S. Redline, J.N. Henry, J.E. Getsy, D.F. Dinges Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. American Journal of Respiratory and Critical Care Medicine 147: Pamidi, S., K.L. Knutson, F. Gohds, B. Mokhlesi The impact of sleep consultation prior to a diagnostic polysomnogram on continuous positive airway pressure adherence. Chest 141(1): Parikh, R., M.N. TouVelle, H. Wang, S. Nath Zallek Sleep Telemedicine: Patient Satisfaction and Treatment Adherence. Telemedicine and e-health 17(8): Van Maanen, J.P., W. Richard, E.R. van Kesteren, M.J. Ravesloot, D.M. Laman, A.A. Hilgevoord, N. de Vries Evaluation of a new simple treatment for positional sleep apnoea patients. Journal of Sleep Research 21(3): Eijsvogel, M., F. de Jongh, M. Brusse-Keizer Sleep Position Trainer vs. Tennis Ball Technique in positional OSA [Abstract]. Barcelona: European Respiratory Society Annual Congress 2013;42(57): Dieltjens, M., A.V. Vroegop, A. Verbruggen, M. Willemen, J.A. Verbraecken, P.H. van de Heyning, M.J. Braem, N. de Vries & O.M. Vanderveken Effect of Sleep Position Trainer and Mandibular Advancement Devices on residual Positional Sleep Apnea under MAD therapy: a randomized clinical trial. Prevention and Research 2(3-Suppl. II):174-5; Oral Presentation, American Academy of Dental Sleep Medicine (AADSM), Baltimore, USA Van Maanen, J.P., De Vries, N Long-term effectiveness and compliance of positional therapy with the Sleep Position Trainer in the treatment of positional obstructive sleep apnea syndrome. Sleep. 37: More information? For more information and contact details visit NightBalance BV. All rights reserved.

16 August 2014 Abstracts of clinical studies with the SPT The Sleep Position Trainer: a new treatment for Positional Obstructive Sleep Apnoea J. Peter van Maanen 1,3, Kristel A. W. Meester 2, Lideke N. Dun 1, Ioannis Koutsourelakis 1, Birgit I. Witte 4, D. Martin Laman 2, Antonius A. J. Hilgevoord 2, Nico de Vries 1 Background Positional Obstructive Sleep Apnoea (POSA), defined as a supine Apnoea Hypopnoea Index (AHI) twice or more as compared to the AHI in the other positions, occurs in 56 % of obstructive sleep apnoea patients. Positional Therapy (PT) is one of several available treatment options for these patients. So far, PT has been hampered by compliance problems, mainly because of the usage of bulky masses placed in the back. In this article, we present a novel device for treating POSA patients. Methods Patients older than 18 years with mild to moderate POSA slept with the Sleep Position Trainer (SPT), strapped to the chest, for a period of 29±2 nights. SPT measures the body position and vibrates when the patient lies in supine position. Results Thirty-six patients were included; 31 patients (mean age, 48.1±11.0 years; mean body mass index, 27.0±3.7 kg/m 2 ) completed the study protocol. The median percentage of supine sleeping time decreased from 49.9% [ %] to 0.0% [range, %] (p<0.001). The median AHI decreased from 16.4 [ ] to 5.2 [ ] (p<0.001). Fifteen patients developed an overall AHI below five. Sleep efficiency did not change significantly. Epworth Sleepiness Scale decreased significantly. Functional Outcomes of Sleep Questionnaire increased significantly. Compliance was found to be 92.7% [ %]. Conclusions The Sleep Position Trainer applied for 1 month is a highly successful and well-tolerated treatment for POSA patients, which diminishes subjective sleepiness and improves sleep-related quality of life without negatively affecting sleep efficiency. Further research, especially on long-term effectiveness, is ongoing. Department of Otorhinolaryngology, Head and Neck Surgery 1, Department of Clinical Neurophysiology 2, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands Department of Otorhinolaryngology, Head and Neck Surgery 3, Academic Medical Center, Amsterdam, The Netherlands Department of Epidemiology and Biostatistics 4, VU University Medical Centre, Amsterdam, The Netherlands Article: Van Maanen, J.P., K.A. Meester, L.N. Dun, I. Koutsourelakis, B.I. Witte, D.M. Laman, A.A. Hilgevoord & N. de Vries The Sleep Position Trainer: a new treatment for Positional Obstructive Sleep Apnoea. Sleep and Breathing 17(2): Long-term effectiveness and compliance of positional therapy with the Sleep Position Trainer in the treatment of positional obstructive sleep apnea syndrome J. Peter van Maanen, MD 1, Nico de Vries, MD, PhD 1 Study objectives To investigate effectiveness, long-term compliance and effects on subjective sleep of the Sleep Position Trainer (SPT) in position-dependent obstructive sleep apnea (POSAS) patients. Methods Prospective, multicenter cohort study. Adult patients with mild and moderate POSAS were included. Patients would use the SPT for 6 months. At baseline and after 1, 3 and 6 months questionnaires would be filled in: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Functional Outcomes of Sleep Questionnaire (FOSQ) and questions related to SPT use. Results 145 patients were included. SPT use and SPT data could not be retrieved in 39 patients. In the remaining 106 patients, median percentage of supine sleep decreased rapidly during SPT s training phase (day 3 to 9) to near total avoidance of supine sleep. This decrease was maintained during the following months of treatment (21% at baseline vs. 3% at 6 months). SPT compliance, defined as more than 4 hours of nightly use, was 64.4%. Regular use, defined as more than 4 hours of usage over 5 nights per week, was 71.2%. Subjective compliance and regular use were 59.8% and 74.4%, respectively. Median ESS (11 to 8), PSQI (8 to 6) and FOSQ (87 to 103) values significantly improved compared to baseline. Conclusions Positional therapy using the SPT effectively diminishes percentage of supine sleep and subjective sleepiness and improves sleep-related quality of life in patients with mild to moderate POSAS. SPT treatment is long-lasting in its effects. SPT has a high compliance and regular use rate. Subjective and objective compliance data correspond well. Department of Otorhinolaryngology, Head and Neck Surgery 1, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands Article: Van Maanen, J.P., De Vries, N Long-term effectiveness and compliance of positional therapy with the Sleep Position Trainer in the treatment of positional obstructive sleep apnea syndrome. Sleep. 37:

17 August 2014 Abstracts of clinical studies with the SPT Sleep Position Trainer vs Tennis Ball Technique in Positional OSA Michiel Eijsvogel, MD 1, Dr. Frans de Jongh 2 and Dr. Marjolein Brusse-Keizer 3 Introduction Standard tennis ball techniques like the Positional Band (PB) can be as effective as CPAP in Positional OSA (POSA) but compliance is low. Objectives Can compliance of Positional Therapy in POSA be improved with a new device, the Sleep Position Trainer (SPT) and have the same effectiveness as PB? Therapies The SPT is a small in supine position vibrating device, placed on the ventral thorax. Body position and temperature sensors are build in, data can be stored and read out giving hours of use and supine position time. The PB is a belt with three inflatable airbags worn on the back preventing supine position. Methods: 55 new patients with POSA were randomized to SPT (29) or PB (26). Standard home-psg was done at baseline and after 1 month therapy. Quebec Sleep Questionnaire (QSQ), ESS and VAS scores were taken. The SPT device was, in a non-vibrating mode, also build in the PB to measure daily compliance in both groups. Results Comparing PSG: AHItot, AHIsup, %suptst was respectively 11.4, 30.7, 27.9% for SPT and 13.2, 37.3, 31.1% for PB. After 1 month the same parameters were respectively reduced to 3.9, 0.0, 0.0 for SPT and 5.8, 0.0, 0.0 for PB. After 1 month therapy also no differences in QSQ, ESS, PSG sleep parameters were observed, however perceived therapeutic effectiveness by means of VAS was 74,5 for SPT and 55,2 for PB (p=0.02). Compliance decreased in both groups with time. At 1 month compliance was 70% for SPT, 42% for PB. Compliance expressed as use >4 hours/night for >5 days/week was 76% for SPT, 42% for PB (p=0.01). Dropouts were 7% in SPT, 28% in PB. Conclusions SPT and PB effectively treat POSA when used. Only the SPT does have an acceptable compliance after 1 month. Pulmonary and Sleep Department 1, Pulmonary Department 2 and Epidemiology Department 3, Medisch Spectrum Twente, Enschede, The Netherlands Preliminary study results were presented at the World Congress on Sleep Apnea, Rome 2012 (oral session) & at the European Respiratory Society (ERS), Barcelona 2013 (poster discussion session). Effect of Sleep Position Trainer and Mandibular Advancement Devices on residual Positional Sleep Apnea under MAD therapy: a randomized clinical trial Marijke Dieltjens 1,2,5, Anneclaire V. Vroegop 2,5, Annelies Verbruggen 2,5, Marc Willemen 3, Johan A. Verbraecken 3,4,5, Paul H. Van De Heyning 2,3,5, Marc J. Braem 1,5, Nico De Vries 6, Olivier M. Vanderveken 2,3,5 Introduction Positional Obstructive Sleep Apnea (POSA), defined as having a supine Apnea/Hypopnea Index (AHI) of at least twice as high as compared to the non-supine AHI, occurs in about 56% of patients with obstructive Sleep Apnea (OSA). Body position during sleep is known to affect the severity of OSA in many, although not in all patients with OSA. The aim of this prospective randomized controlled trial was to investigate the additional effect of a new Sleep Position Trainer (SPT) in patients with residual POSA under Mandibular Advancement Device (MAD) therapy. Methods In 17 patients (age: 51±11y; Male/Female: 10/7; AHI: 22±12/h) with residual POSA under MAD therapy, the additional effect of a chest-worn SPT (NightbalanceTM, Delft, The Netherlands) was studied. The SPT continuously monitors sleep position, vibrating as long as in supine position. After baseline polysomnography (PSG) and PSG with MAD, the patients with residual POSA under MAD therapy were invited for 2 PSGs in randomized order: with SPT alone and with the combination of SPT and MAD. Department of Special Care Dentistry 1, ENT Department and Head and Neck Surgery 2, Multidisciplinary Sleep Disorders Centre 3 and Pulmonary Medicine 4, Antwerp University Hospital (UZA), Antwerp, Belgium Faculty of medicine and health sciences 5, University of Antwerp, Antwerp, Belgium Department of Otolaryngology/Head Neck Surgery 6, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands Results Both MAD and SPT were individually effective in reducing the total AHI significantly when compared to baseline, from 22.2 ± 11.5/h to 11.4 ± 5.2/h and to 11.6 ± 8.7/h respectively. Combination of SPT with MAD therapy further reduced the OSA severity to an AHI of 5.3 ± 3.1/h. This was significantly lower when compared to baseline (p=0.001), MAD alone (p=0.001) and SPT alone (p=0.004). The SPT was found to be effective in reducing the time spent in supine position during sleep compared to baseline and compared to MAD, from 31.4 ± 27.0% to 2.3 ± 7.3% (p=0.001) and from 42.8 ± 15.6% to 2.3 ± 7.3% (p<0.001) respectively. The time spent in supine position during sleep with combination of SPT and MAD was 0.8 ± 1.7, and was significantly lower than baseline (p=0.001) or MAD alone (p<0.001). Conclusions The results of this randomized controlled trial indicate that the combination of the Sleep Position Trainer with MAD therapy leads to a lower time spent in supine position during sleep. The Positional Therapy used in this study effectively reduced the AHI in patients with residual POSA under MAD treatment. Abstract: Dieltjens, M., A.V. Vroegop, A. Verbruggen, M. Willemen, J.A. Verbraecken, P.H. van de Heyning, M.J. Braem, N. de Vries & O.M. Vanderveken Effect of Sleep Position Trainer and Mandibular Advancement Devices on residual Positional Sleep Apnea under MAD therapy: a randomized clinical trial. Prevention and Research 2(3 - Suppl. II): Preliminary study results were presented at the World Congress on Sleep Apnea, Rome 2012 & at the American Academy of Dental Sleep Medicine (AADSM) Baltimore 2013 (oral sessions).

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