Oral Appliances and their Clinical Disclosures Indications in OSA Research Support: SomnoMed Ltd Andrew Chan, MB BS, PhD, FRACP, FCCP Staff Specialist, Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, University of Sydney, Australia 20 th Annual Advances in the Diagnosis and Treatment of OSA and Snoring Types of Oral Appliances Outline › Mandibular Advancement Splints (MAS) › Types of Oral Appliances › Efficacy of Mandibular Advancement Splints in OSA › Comparison of Mandibular Advancement Splints to › Tongue Stabilising Devices Positive Pressure Therapy › Clinical Indications for Oral Appliances › Prediction of Treatment Response › Orofacial Orthopedics (eg. › Future directions Rapid Maxillary Expansion)
Mandibular Advancement Splints (MAS) Examples of MAS Designs › Also known as Mandibular Advancement Device (MAD) One-piece or Mandibular Repositioning Appliance (MRA) (monobloc) › Many designs – one-piece vs two-piece › Customized vs non-customized › Adjustable vs non-adjustable › Different coupling mechanisms, materials, vertical Two-piece opening, lateral movement (duobloc) Efficacy of MAS Efficacy: RCTs of CPAP vs MAS Definition of No. of studies Average Success Success Rate (%) AHI < 5/hour 8 42 AHI<10/hour 30 52 AHI<50% 10 65 compared to baseline Ferguson et al, Sleep, 2006
Symptomatic Outcomes Outcome Effect of MAS (compared to CPAP) Snoring 1 Very high subjective response rate. Objective reductions in snoring intensity and frequency Sleepiness 2,3 Improved ESS. No difference between MAS and Aug 08 Update CPAP Neurocognitive Placebo effect. Inconsistent results. No clear • Compared to: function 2,3 evidence of differential effect of MAS or CPAP – Inactive oral appliances (6) Quality of Life 2,3 Improved QOL. No difference in FOSQ, and SF-36 – CPAP (10) between MAS and CPAP. – Surgery (1) Mood 2 Few studies. Improved POMS, BDI, and HADS • N=831 scores. Inconsistent differences between MAS and • Mild to moderate OSA CPAP • Mostly middle aged men 1. Schmidt-Nowara et al, Sleep 1995 2. Engleman et al, AJRCCM, 2002; Barnes et al, AJRCCM, 2004; Naismith et al, J Clin Sleep Med 2005 3. Gagnadoux et al, ERJ, 2009 Cochrane Review on Objective Health Outcomes with MAS Oral Appliances for OSA Outcome Effect of MAS Objective Sleepiness 1 Improved MSLT at 1 mth. No difference “CPAP appears to be more effective in between MAS and CPAP effect on MWT. Similar improvement in Osler. improving sleep disordered breathing than Psychomotor speed 2 Improved psychomotor speed at 1 mth OA. The difference in symptomatic response Driving simulator Improved driving performance (reduced between these two treatments is NOT performance 3 attention lapses) at 2-3mths. No difference between MAS and CPAP. significant…” 24 hr blood pressure 4 Reduced mean blood pressure at 4 & 12 wks Endothelial function & Improved at 1 yr oxidative stress 5 1. Gotsopoulos et al, AJRCCM 2002; Engleman et al, AJRCCM, 2002; Barnes et al, AJRCCM, 2004; Gagnadoux, ERJ, 2009 2. Naismith et al, J Clin Sleep Med 2005 3. Hoekema et al, Sleep Breath, 2007 4. Gotsopoulos et al, Sleep, 2004; Barnes et al, AJRCCM, 2004 Lim et al, Cochrane Database of Systematic Reviews, 2006 5. Itzhaki et al, Chest 2007
CPAP vs MAS: Equivalence in Effectiveness? “MASPAP” Study Design BASELINE EVALUATION CPAP MAS CPAP MAS Acclimatization MAS CPAP MAS CPAP WASHOUT 2 weeks CPAP MAS 4 weeks 4 weeks END-POINT EVALUATION 1 WASHOUT 2 weeks MAS CPAP 4 weeks 4 weeks The “MASPAP” Study, funded by NHMRC of Australia. END-POINT EVALUATION 2 ACTRN12607000289415 Phillips CL et al, AJRCCM 2013 (In Press) Measurements Baseline Characteristics Variable Entire Mild Moderate Severe Group OSA OSA › Epworth Sleepiness Scale (ESS) (±SD) OSA 15 ≤ AHI<30 AHI ≥ 30 5 ≤ AHI<15 Number 126 23 69 34 82% Male / Female 102/24 15/8 56/13 31/3 › Functional Outcomes of Sleep Questionnaire (FOSQ) Demographics / Anthropometry Age (yrs) 49.5±11.2 50.1±11 48.4±11.3 51.6±11.1 BMI (kg/m 2 ) 29.5±5.5 28.3±6.3 29.3±5.7 30.6±4.6 › Polysomnography Waist Circ (cm) 101.3±15.8 96.8±10.8 99.2±17.0 106.6±14 Neck Circ (cm) 40.5±3.8 38.9±3.7 40.0±3.6 42.3±3.6 Polysomnography › 24hr Ambulatory Blood Pressure AHI (/hr) 25.4±12.5 11.7±2.1 21.6±4.2 42.3±10.4 ODI (3%) 20.8±12.5 12.8±4.9 18.4±9.2 31.5±15.1 SaO2T<90% 5.4±8.8 2.9±4.9 4.4±6.2 9.6±13.8 › Pulse wave analysis / aortic blood pressure Arousal Index (/hr) 34.3±15.3 28.8±15.8 32.2±14.7 43.2±12.8 Quality of Life ESS 9.1±4.2 9.1±3.7 9.2±3.8 8.9±5.1 FOSQ 16.4±2.5 16.0±2.4 16.5±2.5 16.4±2.6 › Driving simulator performance (AusEd) Office BP SBP (mmHg) 123.7±14.1 123±15.3 122.1±12.1 126.7±16.1 DBP (mmHg) 80.6±9.1 81.1±9.7 79.6±8.5 82.0±9.8 › Compliance (subjective, and objective for CPAP) Medication 38% Anti-Hypertensive 48 10 23 15 Anti-Diabetic 7 2 4 1
PSG Outcomes Treatment Compliance – Self Report Variable Baseline CPAP MAS (Mean ± SE) Mean MAS use 6.28+1.5 hrs AHI (hr -1 ) 11.1±1.2** ‡ 26.1±1.2 4.5±0.7** ODI 3% (hr -1 ) 5.6±1.0** 8.9±1.2** ‡ 21.4±1.3 87±0.6** ‡ Min SaO2 (%) 82±0.7 91±0.5** SaO2 T90 (% TST) 5.6±0.9 6.5±2 5.5±1.4 Arousal Index (hr -1 ) 34.4±1.6 16.5±1.1** 19.0±1.2** ‡ Sleep latency (min) 50.0±7.3 11.5±1.5** 15.4±2.1** Sleep efficiency (%) 77.1±1.5 82.0±1.1** 82.2±1.2** Mean CPAP use 5.1+2.0 hrs REM (%TST) 16.6±0.6 17.1±0.5 17.9±0.5** ** p<0.01 for comparison with baseline, ‡ p<0.05 for MAS versus CPAP Summary of Results Long-term Effectiveness › Continued long term benefit at 5 › CPAP was superior to MAS in controlling OSA years › Compliance with MAS was superior to CPAP (at least › 90% still using treatment subjective) › Continued symptom control › MAS was non-inferior to CPAP in terms of impact on a › Continued PSG efficacy(82% range of health outcomes, including: AHI<10/hr), even in those with severe OSA at baseline - Blood pressure outcomes (peripheral and central) › Need for appliance replacement - Sleepiness (32%) - Driving simulator performance › Regular medical & dental follow- up required - Quality of life (MAS superior in some domains) Marklund et al, Chest 2001 Phillips CL et al, AJRCCM 2013 (In Press)
Treatment Preference Adherence › High self-reported nightly compliance (Gotsopoulos et al, AJRCCM 2002; Gagnadouz et al,ERJ,2009) › Average adherence of 77% at 1 year (Ferguson et al, Sleep 2006) › 90% continued use at 5 years in short-term responders (Marklund et al, Chest 2001) › Relapse usually due to weight gain or appliance deterioration (Marklund et al, Chest 2004) › Compared with CPAP adherence – 46-83% patients are nonadherent (ie. use CPAP ≤ 4hrs per night) (Weaver & Grunstein, PATS 2008) Long-Term Side Effects Acute Side Effects 1992 1992 2001 › Compared to control: - Jaw discomfort - Tooth tenderness 1996 - Excessive salivation › Generally mild › Comparable to CPAP in terms of severity and frequency, albeit different profile � Retroclination of the maxillary incisors 2001 � Distal tipping of the maxillary molars � Proclination of the mandibular incisors � Mesial tipping of the mandibular molars Gotsopoulos et al AJRCCM 2002 Courtesy: Prof Alan Lowe, University of British Columbia Gagnadouz et al, ERJ, 2009
Comparison of Treatment Performance: AASM Practice Parameters 2005 MAS vs CPAP PSG efficacy “Although not as efficacious as CPAP, oral Cost- Symptom control appliances are indicated for use in patients with effectiveness mild to moderate OSA who prefer OAs to CPAP, or who do not respond to CPAP, are not ? appropriate candidates for CPAP, or who fail treatment attempts with CPAP or treatment with Health Convenience benefits behavioral measures such as weight loss or sleep position change.” (Guideline) Patient & partner Adherence acceptance CPAP Kushida et al, Sleep, 2006 MAS Chan & Cistulli, Cur Opin Pulmon Med, 2009 Tolerance Single Night Titration of MAS Clinical Protocol › Multidisciplinary approach - Physician (OSA diagnosis, dental referral, evaluation of treatment response, medical follow-up) - Dentist (suitability for and choice of OA, supervise titration, monitor response and side-effects, dental follow-up) › Identify responsiveness to MAS on single-night PSG › Titration Protocol › Analogous to CPAP titration - Initial advancement to 50-60% of maximum › High PPV, and very good NPV - Incremental advancement over weeks or months › Identify target advancement Dort et al, ERJ, 2006 - Appropriate end-point of titration? Tsai et al. AJRCCM, 2004
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