Oral Appliances and their Clinical Indications in OSA

Transcription

1 Oral Appliances and their Clinical Indications in OSA Disclosures Andrew Chan, MB BS, PhD, FRACP, FCCP Staff Specialist, Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, University of Sydney, Australia Research Support: SomnoMed Ltd 20 th Annual Advances in the Diagnosis and Treatment of OSA and Snoring Outline Types of Oral Appliances Types of Oral Appliances Mandibular Advancement Splints () Efficacy of Mandibular Advancement Splints in OSA Comparison of Mandibular Advancement Splints to Positive Pressure Therapy Tongue Stabilising Devices Clinical Indications for Oral Appliances Prediction of Treatment Response Future directions Orofacial Orthopedics (eg. Rapid Maxillary Expansion)

2 Mandibular Advancement Splints () Examples of Designs Also known as Mandibular Advancement Device (MAD) or Mandibular Repositioning Appliance (MRA) Many designs one-piece vs two-piece Customized vs non-customized Adjustable vs non-adjustable Different coupling mechanisms, materials, vertical opening, lateral movement One-piece (monobloc) Two-piece (duobloc) Efficacy of Efficacy: RCTs of vs Definition of Success No. of studies Average Success Rate (%) AHI < 5/hour AHI<10/hour AHI<50% compared to baseline Ferguson et al, Sleep, 2006

3 Symptomatic Outcomes Outcome Effect of (compared to ) Snoring 1 Sleepiness 2,3 Neurocognitive function 2,3 Quality of Life 2,3 Mood 2 Very high subjective response rate. Objective reductions in snoring intensity and frequency Improved ESS. No difference between and Placebo effect. Inconsistent results. No clear evidence of differential effect of or Improved QOL. No difference in FOSQ, and SF-36 between and. Few studies. Improved POMS, BDI, and HADS scores. Inconsistent differences between and 1. Schmidt-Nowara et al, Sleep Engleman et al, AJRCCM, 2002; Barnes et al, AJRCCM, 2004; Naismith et al, J Clin Sleep Med Gagnadoux et al, ERJ, 2009 Compared to: Inactive oral appliances (6) (10) Surgery (1) N=831 Mild to moderate OSA Mostly middle aged men Aug 08 Update Cochrane Review on Oral Appliances for OSA Objective Health Outcomes with Outcome Effect of appears to be more effective in improving sleep disordered breathing than OA. The difference in symptomatic response between these two treatments is NOT significant Objective Sleepiness 1 Psychomotor speed 2 Driving simulator performance 3 Improved MSLT at 1 mth. No difference between and effect on MWT. Similar improvement in Osler. Improved psychomotor speed at 1 mth Improved driving performance (reduced attention lapses) at 2-3mths. No difference between and. 24 hr blood pressure 4 Reduced mean blood pressure at 4 & 12 wks Endothelial function & oxidative stress 5 Improved at 1 yr Lim et al, Cochrane Database of Systematic Reviews, Gotsopoulos et al, AJRCCM 2002; Engleman et al, AJRCCM, 2002; Barnes et al, AJRCCM, 2004; Gagnadoux, ERJ, Naismith et al, J Clin Sleep Med Hoekema et al, Sleep Breath, Gotsopoulos et al, Sleep, 2004; Barnes et al, AJRCCM, Itzhaki et al, Chest 2007

4 vs : Equivalence in Effectiveness? PAP Study Design BASELINE EVALUATION Acclimatization WASHOUT 2 weeks 4 weeks END-POINT EVALUATION 1 4 weeks 4 weeks WASHOUT 2 weeks 4 weeks The PAP Study, funded by NHMRC of Australia. ACTRN END-POINT EVALUATION 2 Phillips CL et al, AJRCCM 2013 (In Press) Measurements Baseline Characteristics Epworth Sleepiness Scale (ESS) Functional Outcomes of Sleep Questionnaire (FOSQ) Polysomnography 24hr Ambulatory Blood Pressure Pulse wave analysis / aortic blood pressure Driving simulator performance (AusEd) Compliance (subjective, and objective for ) Variable Entire Mild Moderate Severe Group OSA OSA (±SD) OSA 15 AHI<30 AHI 30 5 AHI<15 Number Male / Female 102/24 15/8 56/13 31/3 Demographics / Anthropometry Age (yrs) 49.5± ± ± ±11.1 BMI (kg/m 2 ) 29.5± ± ± ±4.6 Waist Circ (cm) 101.3± ± ± ±14 Neck Circ (cm) 40.5± ± ± ±3.6 Polysomnography AHI (/hr) 25.4± ± ± ±10.4 ODI (3%) 20.8± ± ± ±15.1 SaO2T<90% 5.4± ± ± ±13.8 Arousal Index (/hr) 34.3± ± ± ±12.8 Quality of Life ESS 9.1± ± ± ±5.1 FOSQ 16.4± ± ± ±2.6 Office BP SBP (mmhg) 123.7± ± ± ±16.1 DBP (mmhg) 80.6± ± ± ±9.8 Medication Anti-Hypertensive Anti-Diabetic % 38%

5 PSG Outcomes Treatment Compliance Self Report Variable (Mean ± SE) Baseline Mean use hrs AHI (hr -1 ) 26.1± ±0.7** 11.1±1.2** ODI 3% (hr -1 ) 21.4± ±1.0** 8.9±1.2** Min SaO2 (%) 82±0.7 91±0.5** 87±0.6** SaO2 T90 (% TST) 5.6± ±2 5.5±1.4 Arousal Index (hr -1 ) 34.4± ±1.1** 19.0±1.2** Sleep latency (min) 50.0± ±1.5** 15.4±2.1** Sleep efficiency (%) 77.1± ±1.1** 82.2±1.2** REM (%TST) 16.6± ± ±0.5** Mean use hrs ** p<0.01 for comparison with baseline, p<0.05 for versus Summary of Results Long-term Effectiveness was superior to in controlling OSA Compliance with was superior to (at least subjective) was non-inferior to in terms of impact on a range of health outcomes, including: - Blood pressure outcomes (peripheral and central) - Sleepiness - Driving simulator performance - Quality of life ( superior in some domains) Continued long term benefit at 5 years 90% still using treatment Continued symptom control Continued PSG efficacy(82% AHI<10/hr), even in those with severe OSA at baseline Need for appliance replacement (32%) Regular medical & dental followup required Marklund et al, Chest 2001 Phillips CL et al, AJRCCM 2013 (In Press)

6 Adherence Treatment Preference 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 adherence 46-83% patients are nonadherent (ie. use 4hrs per night) (Weaver & Grunstein, PATS 2008) Acute Side Effects Long-Term Side Effects Compared to control: - Jaw discomfort - Tooth tenderness - Excessive salivation Generally mild Comparable to in terms of severity and frequency, albeit different profile Gotsopoulos et al AJRCCM 2002 Gagnadouz et al, ERJ, Retroclination of the maxillary incisors Distal tipping of the maxillary molars Proclination of the mandibular incisors Mesial tipping of the mandibular molars Courtesy: Prof Alan Lowe, University of British Columbia

7 Costeffectiveness Convenience Comparison of Treatment Performance: vs? PSG efficacy Symptom control Health benefits AASM Practice Parameters 2005 Although not as efficacious as, oral appliances are indicated for use in patients with mild to moderate OSA who prefer OAs to, or who do not respond to, are not appropriate candidates for, or who fail treatment attempts with or treatment with behavioral measures such as weight loss or sleep position change. (Guideline) Patient & partner acceptance Chan & Cistulli, Cur Opin Pulmon Med, 2009 Tolerance Adherence Kushida et al, Sleep, 2006 Clinical Protocol Single Night Titration of 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) Titration Protocol - Initial advancement to 50-60% of maximum - Incremental advancement over weeks or months - Appropriate end-point of titration? Identify responsiveness to on single-night PSG Analogous to titration High PPV, and very good NPV Identify target advancement Dort et al, ERJ, 2006 Tsai et al. AJRCCM, 2004

8 Contraindications Predictors of Treatment Response Temporomandibular joint dysfunction Insufficient teeth (need 8-10 in each arch) Periodontal disease / tooth mobility Need for rapid control of OSA Central sleep apnea / hypoventilation syndromes Anthropomorphic Younger age Female gender Lower BMI Smaller neck circumference Smaller overjet Imaging Nasopharyngoscopy (VP enlargement with ) CT/MRI (VP enlargement with ) Cephalometric (various) Polysomnographic Lower baseline AHI Supine-dependent OSA Oropharyngeal collapse Awake Physiological Measures Flow-volume loops (reduced MIF) High nasal resistance Liu Y et al. Am J Orthod Dentofacial Orthop 2001 Marklund M et al. Chest 1998 Mehta A et al. AJRCCM 2001 Ng AT et al. Sleep 2006 Zeng et al, AJRCCM, 2007 Zeng et al, Sleep, 2008 Chan et al, ERJ, 2010 Combination with other Therapy? Future Research Weight loss Nasal decongestants Positional Therapy Provent Surgery Large scale multi-centre RCT of vs Long term health outcome studies Use of state-of-the-art technologies Focus on moderate to severe OSA Ability to measure objective compliance and efficacy with Cost-effectiveness comparison

9