Oventus: Innovators in Sleep Apnoea Treatment Combination Therapy

Transcription

1 Oventus: Innovators in Sleep Apnoea Treatment Combination Therapy 6 August 2018

2 Why Do We Need Combination Therapy? 2

3 CPAP adherence is poor Adherence is poor 50-60% abandon CPAP within first 12 months 1,2 Adherence (hours of use) rates range from 30-60% 3 Non adherent users Start skipping nights during week one of treatment Remain non adherent 4 16 years after this pattern of poor adherence was first described in the literature it remains largely unchanged 4 1 Propescu et al 2001; 2 Galetke et al 2011; 3 Weaver and Sawyer 2010 ; 4 Weaver & Sawyer 2009

4 Trending Away From FFM FFM Now Reconsidered Why Prescribed? FFM masks require higher pressure than nasal masks to maintain patency. Valentin A et al. Sleep J 2011 Pressure in FFM causes more upper airway obstruction than a nasal mask by either displacing the mandible posteriorly or increasing upper airway collapsibility by virtue of mouthopening. Tero, Sleep J 2011 First choice for Mouth breathers Increased Reimbursement ($20-40) DME Proactively VA due to long wait times for PAP intervention (bad press)

5 Clinical Pathway Triage O2 Vent Airway Results of Poor Mask Fit 50% of patients quit CPAP therapy within the first year Poor mask fit leads patients, on average, to try 3 5 generic masks in the first month. Patients who switched their mask are at a seven-fold higher risk for abandoning therapy after switch than those who did not. Mask acceptance is correlated with fewer mask leaks (p=0.002) and higher pressure therapy (p=0.042) O 2 Vent Airway 1. Borel JC, Tamisier R, Dias-Domingos S, et al. Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One 2013;8:e Budhiraja R, Parthasarathy S, Drake CL, et al. Early CPAP use identifies subsequent adherence to CPAP therapy. Sleep 2007;30: J Clin Sleep Med 2016;12(9): and Deshpande et al.j Clin Sleep Med 2016;12(9): Rohit Budhiraja, MD1,2; Jessie P. Bakker, BS, MS, PhD1 3. Valentin A et al. Sleep J Tero, Sleep J Bachour et al. Sleep J 2016

6 Oral Appliances Not Efficacious For All Patients Mandibular advancement splints (MAS) are not as efficacious as continuous positive airway pressure (CPAP) Effectiveness of both treatments on general health outcomes, cognitive function, and quality of life appears to be equivalent The main barrier for the implementation of MAS treatment in clinical practice is the interindividual variability in response to MAS treatment. Several prediction tools have been proposed to enhance patient selection for MAS treatment Phenotyping obstructive sleep apnea patients may reveal patient characteristics that enable the prediction of response to MAS treatment Bamagoos AA1, Sutherland K2, Cistulli PA3. Sleep Med Clin Sep;11(3): doi: /j.jsmc Epub 2016 Jun 17. Mandibular Advancement Splints. 6

7 Our Sleep Treatment Platform is personalising sleep medicine More patients achieving success* with minimal intervention Traditional lower jaw advancement (competitor products) Oventus O 2 Vent Oventus O 2 Vent + EPAP Oventus O 2 Vent + Connect Cumulative Treatment Success Using Oventus Treatment Platform Mandibular advancement splints % 1 of patients treated successfully 54% 1 of patients treated successfully 78% 2 of patients treated successfully 100% 3 of patients treated successfully Patients experienced significant improvement in snoring using O 2 Vent 1. Karen McCloy, Damian Lavery, Julia Moldavtsev, Airway open-airway closed: The effect of mandibular advancement therapy for obstructive sleep apnoea with and without a novel in-built airway. Abstract Submitted Sleep DownUnder Brisbane Victor Lai, Benjamin Tong, Carolin Tran, Andrea Ricciardiello, Michelle Donegan, Nicholas Murray, Jayne Carberry and Danny Eckert Combination therapy with mandibular advancement and expiratory positive airway pressure valves reduces OSA severity. Abstract Submitted Sleep DownUnder Brisbane Amatoury J, Tong B, Nguyen C, Szollosi I, Eckert DJ THE ROLE OF A NOVEL ORAL APPLIANCE THERAPY DEVICE ON PHARYNGEAL PRESSURE SWINGS AND CPAP REQUIREMENTS DURING SLEEP IN OBSTRUCTIVE SLEEP APNEA: A PILOT STUDY. Abstract Supplement AADSM Boston 2017 * Traditional Jaw Advancement mouth guard * AHI < 10 and 50% reduction 20 0 MAS MAS + AIRWAY + EPAP 1 MAS + AIRWAY MAS + PAP 7

8 What Is Oventus Airway Technology Doing and How Can Clinicians Use it? A Personalised Approach to Medicine Ability to treat nasal obstructers as well as non-nasal obstructers Lavery D, Hart C et al. Safety and Efficacy of a Novel Oral Appliance in the Treatment of Obstructive Sleep Apnea. Journal of Dental Sleep Medicine Vol.4 No.3 July 2017 Benjamin Tong, Jason Amatoury, Jayne Carberry and Danny Eckert. The effects of posture and mandibular advancement on nasal resistance and obstructive sleep apnea treatment outcome with a novel oral appliance therapy device. Neuroscience Research Australia (NeuRA) and the University of New South Wales, Sydney, Australia. Poster and Abstract World Sleep Prague Where Mandibular advancement alone may not be able to Zeng B, Ng AT, Qian J, Petocz P, Darendeliler MA, Cistulli PA. Influence of nasal resistance on oral appliance treatment outcome in obstructive sleep apnea. Sleep 2008 Apr;31(4):543-7 Ng AT1, Qian J, Cistulli PA. Oropharyngeal collapse predicts treatment response with oral appliance therapy in obstructive sleep apnea. Sleep 2006 May;29(5):666-7 Prescinotto R1, Haddad FL2, Fukuchi I3, Gregório LC2, Cunali PA4, Tufik S2, Bittencourt LR5. Impact of upper airway abnormalities on the success and adherence to mandibular advancement device treatment in patients with Obstructive Sleep Apnea Syndrome. Braz J Otorhinolaryngol Nov-Dec;81(6): doi: /j.bjorl Epub 2015 Sep 7.

9 What Is Oventus Airway Technology Doing and How Can Clinicians Use it? A Personalised Approach to Medicine Reduces pharyngeal pressure swings (collapsibility) and reduces residual events compared to MAS alone Walsh J, Pantin C, Lim A, Maddison K, Baker V, Szollosi I, McArdle N, Hillman D, Eastwood P. The Effect of a Novel Oral Appliance Therapy on Obstructive Sleep Apnoea: Preliminary Results. Abstract Sleep DownUnder Auckland 2017 Amatoury J, Tong B, Nguyen C, Szollosi I, Eckert DJ THE ROLE OF A NOVEL ORAL APPLIANCE THERAPY DEVICE ON PHARYNGEAL PRESSURE SWINGS AND CPAP REQUIREMENTS DURING SLEEP IN OBSTRUCTIVE SLEEP APNEA: A PILOT STUDY. Abstract Supplement AADSM Boston 2017

10 What Is Oventus Airway Technology Doing and How Can Clinicians Use it? A Personalised Approach to Medicine MAS + Airway Increases response rate in MAS non-responders. Karen McCloy, Damian Lavery, Julia Moldavtsev, Airway open-airway closed: The effect of mandibular advancement therapy for obstructive sleep apnoea with and without a novel in-built airway. Abstract Submitted Sleep DownUnder Brisbane 2018 MAS + Airway + EPAP Increases response rate in MAS + Airway non-responders Victor Lai, Benjamin Tong, Carolin Tran, Andrea Ricciardiello, Michelle Donegan, Nicholas Murray, Jayne Carberry and Danny Eckert Combination therapy with mandibular advancement and expiratory positive airway pressure valves reduces OSA severity. Abstract Submitted Sleep DownUnder Brisbane 2018

11 What Is Oventus Airway Technology Doing and How Can Clinicians Use it? A Personalised Approach to Medicine Reduces CPAP pressure requirements, eliminates the need for a full face mask and allows mouth breathing while delivering ncpap Amatoury J, Tong B, Nguyen C, Szollosi I, Eckert DJ THE ROLE OF A NOVEL ORAL APPLIANCE THERAPY DEVICE ON PHARYNGEAL PRESSURE SWINGS AND CPAP REQUIREMENTS DURING SLEEP IN OBSTRUCTIVE SLEEP APNEA: A PILOT STUDY. Abstract Supplement AADSM Boston 2017 Benjamin Tong, Carolin Tran, Andrea Ricciardiello, Michelle Donegan, Nicholas Murray, Alan Chiang, Irene Szollosi, Jason Amatoury and Danny Eckert. Combination therapy with CPAP plus MAS reduces CPAP therapeutic requirements in incomplete MAS responders. Abstract Submitted Sleep DownUnder Brisbane 2018 Treating nasal obstruction patients where traditional CPAP may not be able to Sugiura T, Noda A, Nakata S, Yasuda Y, Soga T, Miyata S, Nakai S, Koike Y. Influence of nasal resistance on initial acceptance of continuous positive airway pressure in treatment for obstructive sleep apnea syndrome. Respiration. 2007;74(1): Epub 2005 Nov 18.

12 How Oventus Airway Technology is truly differentiated Delivers consistent airflow. Addresses common sites of obstruction. Oventus Airway Technology addresses multiple levels of obstruction. Mandibular positioning primarily manages tongue based obstruction, i.e. 20% of primary obstructions 1 Allowing airflow through Oventus Airway Technology has a similar effect to pumping via CPAP 2 Oventus improves efficacy of oral appliance therapy by 30-50% 2,3 Level of Obstruction or Resistance Incidence of primary collapse (%) Mandibular Advancement Device (MAD) Mandibular Positioning Airway Therapy (Oventus Airway Technology) No Effect Some Effect Definite Effect Combining mandibular advancement with its proprietary oral airway, Oventus Airway Technology uniquely addresses both sites of primary upper airway blockage and secondary airway collapse. Source: 1. Genta PR, et al. CHEST DOI: /j.chest ; 2. Amatoury J, et al. Abstract Supplement ADSM Boston Walsh J, et al. Abstract Sleep Downunder Auckland

13 What is nasal EPAP? Mechanical one-way valve (Provent TM ) applied over each nostril Provides high resistance to expiration -> high airway pressures during expiration -> reduces upper airway collapsibility Hyperinflation of lungs -> increased tracheal traction -> reduces upper airway collapsibility Functional Residual Capacity Upper Airway Area Braga, C. W., et al. (2011). Friedman, M., et al. (2016). Care of Prof Danny Eckert NeuRA

14 Could Nasal EPAP Complement MAS? 1. Nasal EPAP therapy reduces AHI, ODI, arousals per hour and daytime sleepiness 2. MAS primarily widens retro-palatal region and nasal EPAP may widen the hypo-pharyngeal region 3. ~50% of patients on MAS therapy have incompletely resolved OSA AHI with nasal EPAP Could combination therapy of MAS with nasal and oral EPAP reduce OSA severity in these patients? Care of Prof Danny Eckert NeuRA Colrain, I. M., et al. (2008). Oxygen Desaturation Index (ODI): number of >3% oxygen desaturations/hour of sleep Apnoea-hyponoea index (AHI): number of apnoeic ( 90% airflow cessation) or hypopnoeic (>30% airflow cessation with arousal/>3% oxygen desaturation) events/hour of sleep

15 ORAL epap Oventus ExVent TM Controlling Mouth Breathing IMPROVING UPPER AIRWAY PHYSIOLOGY Mouth breathing results from increased resistance in the nose and/or soft palate collapse Increased resistance leads to negative pressure swings that cause arousals and a switch to mouth breathing Mouth breathing leads to a highly unstable airway Oventus Airway Technology + controlled exhalation reduces negative pressure swings and AHI while simultaneously increasing internal pressure in the airway and/or maintaining stability during exhalation with or without ncpap The valve at the front of the airway or ExVent TM achieves this

16 Oventus Airway Technology + PEEP delivering low resistance inhalation and controlled exhalation Soft Palate Collapses and a switch to device breathing occurs Increased nasal resistance Neg pressure swings reduced due to air being delivered through device airway and oropharyngeal airway, supported by PEEP Low resistance inhalation and PEEP targeted to the oropharynx via O 2 ExVent and Oventus Airway

17 Could Nasal EPAP Complement MAS? 1. Nasal EPAP therapy reduces AHI, ODI, arousals per hour and daytime sleepiness 2. MAS primarily widens retro-palatal region and nasal EPAP may widen the hypo-pharyngeal region 3. ~50% of patients on MAS therapy have incompletely resolved OSA AHI with nasal EPAP Could combination therapy of MAS with nasal and oral EPAP reduce OSA severity in these patients? Care of Prof Danny Eckert NeuRA Colrain, I. M., et al. (2008). Oxygen Desaturation Index (ODI): number of >3% oxygen desaturations/hour of sleep Apnoea-hyponoea index (AHI): number of apnoeic ( 90% airflow cessation) or hypopnoeic (>30% airflow cessation with arousal/>3% oxygen desaturation) events/hour of sleep

18 Sydney NeuRA Study Effect of Oral EPAP on MAD + Oventus Airway Technology Treatment Failures (n=13) 69 % of previous O 2 Vent TM treatment failures improved their treatment outcome 44% of O 2 Vent TM treatment failures achieved >50% AHI RDN 33% of previous O 2 Vent TM treatment failures achieved AHI 10 Appears to work well in patients with increased nasal resistance The increased nasal resistance may be working as a natural PEEP valve

19 Sydney NeuRA Study Effect of Oro-nasal EPAP on MAD + Oventus Airway Technology Treatment Failures (n=13) Oro-nasal EPAP ONEPAP Titratable true PEEP valve delivering constant pressure on exhalation 54% of previous O 2 Vent TM treatment failures achieve AHI 10 & >50% RDN 31% of previous treatment failures AHI 5 In Development - Launch 2019

20 A True Titratable PEEP Valve vs Flapper Flapper has a linear flow-pressure curve The harder the patient exhales the higher the pressure ramps to This can cause discomfort and/or feelings of claustrophobia A true PEEP valve the maximum pressure can be set by adjusting the titration mechanism The curve flattens out at a certain pressure level even as flow increases. In Development - Launch 2019

21 MAD + Positional Therapy FOR SUPINE DEPENDENT OSA Positional obstructive sleep apnoea [POSA], commonly defined as supine to non-supine apnoea hypopnea index (AHI) ratio of 2). Twenty patients with sdosa Sleep positional trainer (SPT) reduced the time spent in supine sleeping position compared to baseline and MAD therapy Both MAD and SPT were individually effective in reducing the overall apnea/hypopnea index (AHI) significantly when compared to baseline from 20.8 (15.1; 33.6)/h at baseline to 11.0 (6.7; 13.8)/h and to 11.1 (3.5; 17.7)/h with MAD or SPT, respectively The combination of SPT + MAD further reduced the overall AHI to 5.7 (3.6; 7.4), which was significantly lower than with MAD alone (p < 0.001) and SPT alone (p < 0.008), respectively Dieltjens M1, Vroegop AV, Verbruggen AE, Wouters K, Willemen M, De Backer WA, Verbraecken JA, Van de Heyning PH, Braem MJ, de Vries N, Vanderveken OM. A promising concept of combination therapy for positional obstructive sleep apnea. Sleep Breath May;19(2): doi: /s Epub 2014 Oct 22.

22 NeuRA Nasal Resistance Study (n=7) Results: Awake nasal resistance tended to increase from seated, to supine, to lateral body positions (2.5±0.7, 3.6±1.2, 4.3±1.6 cmh 2 O/ml/s, respectively) Mandibular advancement did not systematically alter nasal resistance in either the seated (3.1±0.9 cmh 2 O/ml/s) or supine positions (4.7±2.1 cmh 2 O/ml/s). Oral appliance therapy reduced the median supine non-rem AHI from 34.4 [5.1, 55.0] to 7.0 [3.1, 22.7] events/h sleep, p=0.03).

23 MAD + PAP CPAP pressure required to eliminate all obstructive events on the combination therapy was reduced from 9.4 ± 2.3 to 7.3 ± 1.4 cm H₂O (p = 0.001) The residual apnea hypopnea index on the MAD decreased from 11.2 ± 3.9 to 3.4 ± 1.5 on the combination therapy (p < 0.001). The number of oxygen desaturations was also less with the combination therapy than with MAD (p < 0.001) Both the MAD and the combination therapy were effective in reducing daytime sleepiness from 12.7 ± 2.1 at baseline to 9.7 ± 3.1 (p = 0.04) and 7.5 ± 4.1 (p = 0.007), respectively. El-Solh AA1, Moitheennazima B, Akinnusi ME, Churder PM, Lafornara AM. Combined oral appliance and positive airway pressure therapy for obstructive sleep apnea: a pilot study. Sleep Breath May;15(2): doi: /s Epub 2010 Nov 10

24 MAD + PAP 14 male patients were included. The residual AHI and ODI on combination therapy (CT) was lower than that on MAD or PAP The residual % TST-SpO2<90% was lower than that on MAD and similar to that on PAP. The therapeutic pressure on CT was on average 9.2 cm H2O lower than that on PAP 19cm H2O For the 11 patients who completed CT, only CT reduced ESS compared to pretreatment value No treatment had significant impact on % slow wave sleep or overnight change of blood pressure For patients who completed CT, the average usage was 5.9±1.7 hr/night at 12th week and 6.4±1.5 hr/night at a median follow-up of 36.5-months. Liu HW1,2, Chen YJ3, Lai YC4, Huang CY3, Huang YL5, Lin MT2,6, Han SY7, Chen CL8, Yu CJ5, Lee PL5,9. Combining MAD and CPAP as an effective strategy for treating patients with severe sleep apnea intolerant to high-pressure PAP and unresponsive to MAD. PLoS One Oct 26;12(10):e doi: /journal.pone ecollection 2017.

25 MAD + PAP 92 OSA patients aged 25 to 85 years (mean 55 years) Mean polysomnogram-determined diagnostic AHI value was 37.6 (standard deviation (sd): 25.9) Half (n=46) met the diagnostic threshold for severe OSA (AHI 30), a quarter (n=23) had moderate OSA (AHI ), and the remainder (n=23) had mild OSA (AHI ) 65 patients (70.7%) tolerated PAP/MAS therapy, having used it for 14.0 months on average (sd: 11.1) Tolerance was higher in patients with severe OSA (76.1%) than mild OSA (69.8%), this difference was not statistically significant (P = 0.421) Patients with severe OSA were more likely to have had the follow-up polysomnogram than those with mild OSA (P = 0.023) In these patients, AHI values decreased from an untreated mean of 48.0 (sd: 28.3) events/hour to a treated mean of 3.1 events/hour (sd: 3.8) (P < 0.001), indicating that, on average, PAP/MAS eliminated OSA.

26 Pilot Study O 2 Vent TM T +/- PAP Connection O 2 Vent TM W AND OPTIMA TM + EXVENT TM +/- Nasal epap or cpap Reduced pressure requirements by 66% Simultaneous ncpap delivery and physiologic mouth breathing Mask and strap free ultra low pressure PAP delivery In Development - Launch 2019 Amatoury J, Tong B, Nguyen C, Szollosi I, Eckert DJ THE ROLE OF A NOVEL ORAL APPLIANCE THERAPY DEVICE ON PHARYNGEAL PRESSURE SWINGS AND CPAP REQUIREMENTS DURING SLEEP IN OBSTRUCTIVE SLEEP APNEA: A PILOT STUDY. Abstract Supplement AADSM Boston 2017

27 Oventus Airway Technology Coming Soon. O 2 Vent TM Connect PAP Connection Nasal PAP delivers pressure and flow PAP P +Q Controlled Exhalation P-Crit Pharyngeal Airway Trachea Controlled exhalation with easy inhalation allows mouth breathing while putting a floor under pharyngeal pressure

28 All of These Results Can Be Achieved From September O 2 VENT TM W AND OPTIMA TM + EXVENT TM +/- NASAL EPAP OR CPAP

29 How Can we use the Oventus Treatment Platform to Enhance Patient Outcomes? A Personalised Approach to Medicine The Oventus Treatment Platform Cumulative Success* MAS 41% Treatment success Cumulative Treatment Success Using Oventus Treatment Platform Oventus O 2 Vent TM 54% Treatment success 1 Oventus O 2 Vent TM + EPAP 78% Treatment Success 2 Oventus O 2 Vent TM + Connect 100% Treatment Success 3 1. Karen McCloy, Damian Lavery, Julia Moldavtsev, Airway open-airway closed: The effect of mandibular advancement therapy for obstructive sleep apnoea with and without a novel in-built airway. Abstract Submitted Sleep DownUnder Brisbane Victor Lai, Benjamin Tong, Carolin Tran, Andrea Ricciardiello, Michelle Donegan, Nicholas Murray, Jayne Carberry and Danny Eckert Combination therapy with mandibular advancement and expiratory positive airway pressure valves reduces OSA severity. Abstract Submitted Sleep DownUnder Brisbane Amatoury J, Tong B, Nguyen C, Szollosi I, Eckert DJ THE ROLE OF A NOVEL ORAL APPLIANCE THERAPY DEVICE ON PHARYNGEAL PRESSURE SWINGS AND CPAP REQUIREMENTS DURING SLEEP IN OBSTRUCTIVE SLEEP APNEA: A PILOT STUDY. Abstract Supplement AADSM Boston 2017 *AHI 10 and >50% reduction MAS MAS + AIRWAY MAS + AIRWAY + EPAP MAS + PAP

30 WHERE TO NEXT?

31 Pharma and Behavioral Therapy Ludovico et al Sleep Breath 2017

32 100% anatomical compromise (but of variable magnitude) MAD + Pharma Targeted non-cpap Interventions for OSA 37% low arousal threshold 36% poor muscle responsiveness 36% unstable respiratory control (high loop gain) Eckert et al, Am J Resp Crit Care Med (2013) & Carberry et al, Chest (2018)

33 Combination therapy: Supplemental O 2 and a hypnotic (eszopiclone) reduces OSA Severity Edwards et al, Sleep (2016)

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35 Oventus Optima TM ExVent TM and ONEPAP TM

36 Comprehensive Dental Sleep Treatment Platform Designed specifically for Sleep Groups The Dental Sleep Program is comprehensive and will assist Sleep Groups to maximise patient outcomes by providing the systems, support, training and resources required to run a professional Dental Sleep Medicine clinic utilising Oventus proprietary airway technology and digital workflow

37 QUESTIONS?

38 THANK YOU