Oral Appliance Therapy for OSA and Measuring Compliance in Custom Oral Devices for OSA. Copyright 2017 BRAEBON

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Bertram Jack Benson
5 years ago
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1 DISCLOSURE Richard A. Bonato, Ph.D., M.A., RPSGT CEO and Co-Founder of BRAEBON Medical Corporation Has been involved in the study of sleep and its disorders since 1986, has taught courses on Sleeping & Dreaming at Carleton University, was the director of a sleep disorders laboratory, and has been an author, co-author, reviewer, and examiner in various educational organizations within the sleep field, including the AASM, AAST, BRPT, and has served on the Executive of the Canadian Sleep Society. BRAEBON manufactures and sells wearable sleep sensors, home apnea recorders, and a micro-recorder, DentiTrac, for tracking oral appliance compliance.

3 Objectives How does OAT (and CPAP) work and how do you know it is working? Compliance and why measure it? Test Treat Trac Technology: understanding what to use Types of patients who may benefit from oral appliance compliance measurement Evaluation of oral appliance success: compliance reporting Copyright 2017 BRAEBON

6 Sleep Disordered Breathing Spectrum

8 Two key questions for DSM: 1. How does OAT work, how do you know oral appliance therapy (OAT) is working for an apnea patient? 2. How do you know if a patient is wearing their oral appliance? Copyright 2017 BRAEBON

10 Change. Omnipresent Very difficult for many people Technology change (Test. Treat. Trac.) What was life like in the year 1900? What was the environmental crisis of the day?

11 Technology we use.. Lab (PSG) vs home (HSAT) Type 1 PSG Type 2 HST Type 3 HSAT Type 4 HSAT Sleep Tech in Sleep Lab 16 or more channels: EEG, EOG, EMG, EKG, Legs Thermal airflow, Pressure airflow, Ventilatory effort, Snoring, Body Pos No Tech, Home (MediPalm/Byte) 7 or more: EEG, EOG, EMG Thermal airflow, Pressure airflow, Ventilatory effort, Snoring, Body Pos No Tech Home (MediByte) No Tech, 4 or more 1 or 2 Thermal airflow, Pressure airflow, Ventilatory effort, Snoring, Body Pos SpO2 SpO2 SpO2 SpO2 Home (Oximeter) Perhaps pressure airflow

12 SCOPER Scale: Collop et al. 2011

13 Polysomnogram = PSG (full PSG or full poly) 1989: >200 lbs; 6 high

14 Full Polysomnograpy (Type 1) 2003: ½ lb; 4.75 x 2.75 x 0.75 (L x W x H)

15 Polysomnogram = multiple sleep graph recording EOG Airflow Chest effort Abdominal effort EEG Chin EMG EKG Body Position SpO2 Legs EMG

16 Type 1

17 With in-lab PSG (Type 1). We can evaluate virtually all sleep disorders (about 90) Plus MSLT & MWT But PSG is NOT a gold standard for OSA There is no anatomical or biological gold standard for OSA Best at the time and we got stuck with it

18 Home sleep apnea testing (HSAT): Type 2 / : 93 grams; 2.75 x 2 x 0.70

19 Type 2 Home Sleep Recording

20 Type 2: EEG, EOG, EMG + cardiopulmonary

21 Unambiguous Stage REM sleep.

23 Type 1 or Type 2

24 EEG During sleep stages Gamma = > 30 Hz EEG Beta = 16 to 30 Hz EEG Alpha EEG = 8 to 12 Hz Theta EEG = 4 to 8 Hz NREM REM Sleep Cycle Sleep Spindle = 12 to 14 Hz Delta EEG = 0.5 to 4 Hz CNV & DC Potentials Copyright 2011 Braebon

27 Simultaneously record: 1. EEG 2. EOG 3. EMG 4. EKG 5. Snore 6. Pressure Airflow 7. Flow Limitation 8. Thermal Airflow 9. Chest Effort 10. Abdominal Effort 11. Sum 12. SpO2 13. Pulse Rate 14. Body Position 15. *PPG (Photoplethysmogram) 16. User Events

28 HSAT Type 3 simpler cardiopulmonary recorder 2008: 91 grams; 2.75 x 2 x 0.70

30 Simultaneously record: 1. Snore 2. Pressure Airflow 3. Flow Limitation 4. Chest Effort 5. SpO2 6. Pulse Rate 7. Body Position 8. *PPG (Photoplethysmogram) 9. User Events

31 Type 4: overnight pulse oximetry

32 Type 4: Pulse Oximetry (+ more?)

33 Simultaneously record: 1. Snore 2. Pressure Airflow 3. Flow Limitation 4. SpO2 5. Pulse Rate 6. *PPG (Photoplethysmogram)

34 DentiTrac micro-recorder 2015: 5 grams; ~12 x 11 x 5 mm

35 What do these devices have in common? They are ALL recorders

36 What do we do with this info? SDB: AHI is often focus Why? Other measures: Arousals, RDI, flow limitation, RERAs, PRV, etc. Goal is successful treatment: CPAP or OAT

37 How does CPAP work? A CPAP machine blows room air into your airway so it doesn't collapse when you breathe in. Interface covers nose (maybe mouth, but nose better) Think of CPAP as an air splint Effective but usually low compliance

39 CPAP (cont d) Bedside blower size is usually not an issue for people Blowers are getting smaller for easier travel: Travel PAP Mask interfaces remain the largest issue for most people

40 How does OAT work? A device is placed in the mouth and holds the mandible and / or tongue forward, usually with increased vertical opening, which acts as a mechanical splint to increase airway space so your airway doesn t collapse (as much) when you breathe in TRD vs MRD

42 How does OAT work? Custom usually better than boil & bite Titratable usually better than non Bite registration? Phonetic George Gauge

43 86% increase in anteriorposterior area

44 How does OAT compare to CPAP? Chan & Cistulli, 2009

45 Are you better off using something that works well (i.e., CPAP with AHI & PSG measures) but using it less OR are you better off using something that does not work quite as well (i.e., OAT) but using it more?

47 Measured cardiovascular (24-h blood pressure, arterial stiffness), subjective sleepiness, driving simulator performance, and quality of life (Functional Outcomes of Sleep Questionnaire-36) Randomly assigned 126 (108 completed) patients with moderate to severe OSA Copyright 2017 BRAEBON

48 CPAP reduced AHI better, but moderate to severe OSA patients were similar after treatment with CPAP and oral appliance. Because patients wear oral appliances more than they wear CPAP. Long-term studies needed to compare CPAP and MAD using objective compliance measurement [e.g., DentiTrac]. Copyright 2017 BRAEBON

62 Pulse Rate Variability from 60 to 120 Overall AHI / RDI = 15.7 / 24.2

63 But supine this person falls into mild.

64 Follow-up: Baseline vs OAT Tx

65 CPAP Noncompliant patient using temp appliance (in a tent) 38 11

68 We ve talked about technology, we ve talked about how CPAP & OAT work, how to measure their success How do you actually know if people are actually complying or adhering to treatment? Copyright 2017 BRAEBON

69 What is compliance? Extent to which a person s behavior (taking meds, following a diet) coincides with medical or health advice (Haynes et al., 1979) Also, adherence, concordance or cooperation (not passive terms, suggest more choice, etc.) For dental sleep medicine or orthodontics: extent to which the person is using prescribed therapy Copyright 2017 Braebon

70 Direct or Indirect compliance measurement Direct: Use physiological measures (airflow, body temp) Less subject to bias This is where CPAP has been Indirect: Self-reports are more frequently used and easier More subject to bias This is where OAT has been Copyright 2017 BRAEBON

71 Why is it important to measure? Better compliance = better results: reduced treatment time (ortho) Noncompliance = waste of resources = insurance payers will no longer pay (CPAP) Copyright 2017 BRAEBON

73 Two Achilles heels of OAT 1. Objective compliance measurement 2. A priori determination of successful OAT candidate

74 Definition of compliance: CPAP To qualify to retain funding for CPAP after an initial 3-month trial, a patient must demonstrate continued use of CPAP therapy : > 4 hrs per night for > 70% of all nights during a 30-day period of the initial 90-day trial Historical def n is >4 hrs nightly five nights per week Copyright 2017 BRAEBON

75 Europe Qualifying for continued CPAP funding France: > 3 hrs per night 7 days per week Germany: > 4 hrs per night Italy: > 3 hours per night Spain: > 5 hours per night Which definition is more correct? Copyright 2017 BRAEBON

79 Let me tell you about our patient Juan Juan is from Columbia Juan is a bit of a round individual Mallampati score of 0 (or less) Weight = 1.36kg and Height = 8 Juan has a BMI of 32.5 Copyright 2017 BRAEBON

84 Gaming CPAP compliance Quick & dirty demonstration of CPAP compliance deception: Cannot guarantee that it is actually that patient wearing that particular CPAP Could be bedpartner or a simple or more sophisticated simulation This has important implications for the future

85 CPAP Compliance / Intolerance When adherence is defined as greater than 4 hours of nightly use, 46 to 83% of patients with obstructive sleep apnea have been reported to be nonadherent to treatment. Weaver & Grunstein (2008). Proc Am Thorac Soc Vol 5. pp , 2008 CPAP Intolerance is a large target market for dentists Copyright 2017 BRAEBON

87 Kribbs, Pack, Kline, Getsy, Schuett, Henry, Maislin, Dinges. Effects of one night without nasal CPAP treatment on sleep and sleepiness in patients with obstructive sleep apnea. Am Rev Respir Dis 1993;147: Sleeping without CPAP for one night reversed virtually all of the sleep and daytime alertness gains derived from sleeping with CPAP. Copyright 2017 BRAEBON

89 What about OAT compliance measurement? AASM OA Practice Parameters: 2005 Adherence data for OAs mostly relies on subjective reports. In contrast, CPAP compliance is routinely monitored objectively. Development of similar capabilities for OA therapy should be pursued for both research and clinical purposes. Copyright 2017 BRAEBON

90 Two Achilles heels of OAT 1. Objective compliance measurement

91 What is OAT compliance? 1. How compliant are you everyday? 2. How compliant are you on days you are wearing it for at least 15 min? 3. How compliant are you > 4 hrs daily for 5 out of 7 days for the entire data collection period? (historical CPAP def n) 4. How compliant are you > 4 hrs daily during a 30-day period of the initial 90-day usage? (this is the new CPAP def n) Copyright 2017 BRAEBON

92 What is OAT compliance? (cont d) 4. How compliant are you if you changed appliances and now have a new one (i.e., more than one)? 5. How compliant are you since the last time we looked (uploaded) at the data?

93 Headgear timer: miniature electronic watch with memory Pts increased wearing time when told about monitoring. Hours increased from / week to 100 / week.

94 Northcutt, M. E. The timing headgear. J. Clin. Orthod. V.8, p , Jun Timing headgear neckband and timer Timing headgear readout monitor Neckband placed on monitor for readout

95 Orthokinetics: Compliance Science System Objectively inform orthodontists and patients the number of hours the headgear is being worn

96 Compliance Science System in 46 patients (blind) After two months two groups set up: uncooperative <16 hrs daily now informed of monitor cooperative > 16 hrs daily remain blind to monitor 4 months later: statistically significant increase in usage in the uncooperative group

97 Creative children found a way around it.

98 Temperature sensor with periodic sampling

111 Auxilary can do much of this: Data is read by the base station and uploaded to the cloud portal for analysis and reporting Reading data is as simple as placing the OA into the base station Copyright 2017 BRAEBON

DentiTrac processed data 1. C everyday = 87% 2.

121 Vanderveken et al. 2013: Thorax Objective compliance measurement & OAT Compared objective and subjective OAT compliance Introduced mean disease alleviation

122 Vanderveken et al Objective OAT compliance measurement allows calculation of mean disease alleviation, defined as a combined function of efficacy and compliance, being a measure of overall therapeutic effectiveness Effectiveness = compliance x efficacy.

123 Vanderveken et al OA efficacy (%) = baseline AHI minus AHI with OA (e.g., = 56%) Mean Disease Alleviation = product of adjusted compliance (worn 91.2% of the time) with therapeutic OA efficacy (56% above = 51.1%

124 Mean disease alleviation

125 CPAP example If the AHI on CPAP drops from 50 to 2 then it is a 96% reduction If the patient only wears the CPAP 50% of the time then Mean Disease Alleviation = 50% x 96% = 48%

126 Vanderveken et al Higher compliance with OAT = similar adjusted effectiveness as compared with CPAP OAT is not as good as CPAP in reducing AHI, but MDA values might be comparable with CPAP because of the higher compliance with OA therapy (and that s what Philips et al said too)

127 More research using objective OA compliance 51 patients with mild to moderate OSA

128 Dieltjens et al JAMA Oto Head & Neck Neither anthropometric & polysomnographic parameters nor reports of excessive daytime sleepiness correlated with OAT compliance Two parameters which correlated with higher OAT objective compliance were decreased snoring and dry mouth

129 Journal Dental Sleep Medicine: 2015 CPAP & OAT have limitations: CPAP Tx often has low patient acceptance, poor tolerance and suboptimal compliance; OAT usually has inferior PSG efficacy when compared to CPAP

130 According to MDA concept. OSA Tx with CPAP, OAT or other non- CPAP modalities, as a single treatment, usually means incomplete elimination of the disorder with average MDA index, as a marker of real clinical effectiveness, ranging from 40 to 59%

131 Vanderveken Greater CPAP efficacy is offset by its inferior compliance relative to OAT This is not imaginary, and results in a similar overall effectiveness for both therapeutic modalities

132 Vanderveken 2015: Combo Tx Mandibular advancement + tongue protrusion = effective treatment for moderate-to-severe OSA: tongue bulb added to MRD provides further therapeutic effectiveness. Dort & Remmers JCSM 2012

133 Vanderveken 2015: Combo Tx OAT + multilevel upper airway surgery OAT + positional Tx Recent study reported MDA increased from 42% to 70% when OAT was combined with positional Tx (Dieltjens et al., 2014)

134 But can we game OAT same as CPAP? It is much more difficult to deceive OAT with DentiTrac objective compliance than to deceive CPAP with Juan My OA won t fit my bedpartner My dog luvs my OA as a chew toy Juan is not a substitute What about a heated water bath?

136 Schott & Goz, Journal of Orofacial Orthopedics, 2010, 79, pp Bϋchi heating bath deception 2 litres of water warmed to 35 C (95 F) between 2100 and 0700 to simulate wearing Off 0700 to 1400 On again 1400 to 1600 and 1700 to 1900 Off 1900 to 2100 Thus, total of 14 hrs wearing & 10 nonwearing every 24 hours Copyright 2017 BRAEBON

137 With a simple temp measurement device, they concluded that the warm water bath could deceive the temperature sensing technology and report wearing when not actually worn The DentiTrac was not susceptible to this deception because more than temperature is being recorded and anti-deception algorithms are implemented Copyright 2017 BRAEBON

138 To conclude: Exciting times for OA Tx OAT compliance measurement is a rapidly expanding frontier of dental sleep medicine New standards evolving Modeled after the existing CPAP compliance paradigm Test. Treat. Trac.

139 Where to go from here? Principles & Practice of Sleep Medicine (6 th Ed) ASBA Diplomate Exam

Prefabricated Oral Appliances for Obstructive Sleep Apnea

Medical Policy Manual Allied Health, Policy No. 36 Prefabricated Oral Appliances for Obstructive Sleep Apnea Next Review: May 2019 Last Review: April 2018 Effective: May 1, 2018 IMPORTANT REMINDER Medical