Oral Appliances and their Clinical Disclosures Indications in OSA - - PowerPoint PPT Presentation

Oral Appliances and their Clinical Indications in OSA

Andrew Chan, MB BS, PhD, FRACP, FCCP Staff Specialist, Department of Respiratory and Sleep Medicine, Royal North Shore Hospital, University of Sydney, Australia

20th Annual Advances in the Diagnosis and Treatment of OSA and Snoring

Disclosures

Research Support: SomnoMed Ltd

Outline

› Types of Oral Appliances › Efficacy of Mandibular Advancement Splints in OSA › Comparison of Mandibular Advancement Splints to Positive Pressure Therapy › Clinical Indications for Oral Appliances › Prediction of Treatment Response › Future directions

Types of Oral Appliances

› Mandibular Advancement Splints (MAS) › Tongue Stabilising Devices › Orofacial Orthopedics (eg. Rapid Maxillary Expansion)

Mandibular Advancement Splints (MAS)

› Also known as Mandibular Advancement Device (MAD)

• r Mandibular Repositioning Appliance (MRA)

› Many designs – one-piece vs two-piece › Customized vs non-customized › Adjustable vs non-adjustable › Different coupling mechanisms, materials, vertical

• pening, lateral movement

Examples of MAS Designs

One-piece (monobloc) Two-piece (duobloc)

Efficacy of MAS

65 10 AHI<50% compared to baseline 52 30 AHI<10/hour 42 8 AHI < 5/hour Average Success Rate (%)

• No. of studies

Definition of Success

Ferguson et al, Sleep, 2006

Efficacy: RCTs of CPAP vs MAS

Symptomatic Outcomes

Very high subjective response rate. Objective reductions in snoring intensity and frequency Snoring1 Improved QOL. No difference in FOSQ, and SF-36 between MAS and CPAP. Quality of Life2,3 Few studies. Improved POMS, BDI, and HADS

• scores. Inconsistent differences between MAS and

CPAP Mood2 Placebo effect. Inconsistent results. No clear evidence of differential effect of MAS or CPAP Neurocognitive function2,3 Improved ESS. No difference between MAS and CPAP Sleepiness2,3

Effect of MAS (compared to CPAP) Outcome

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

• Compared to:

– Inactive oral appliances (6) – CPAP (10) – Surgery (1)

• N=831
• Mild to moderate OSA
• Mostly middle aged men

Aug 08 Update

Cochrane Review on Oral Appliances for OSA

Lim et al, Cochrane Database of Systematic Reviews, 2006

“CPAP 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 Health Outcomes with MAS

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 5. Itzhaki et al, Chest 2007

Outcome Effect of MAS

Objective Sleepiness1 Improved MSLT at 1 mth. No difference between MAS and CPAP effect on MWT. Similar improvement in Osler. Psychomotor speed2 Improved psychomotor speed at 1 mth Driving simulator performance3 Improved driving performance (reduced attention lapses) at 2-3mths. No difference between MAS and CPAP. 24 hr blood pressure4 Reduced mean blood pressure at 4 & 12 wks Endothelial function &

• xidative stress5

Improved at 1 yr

CPAP vs MAS: Equivalence in Effectiveness?

The “MASPAP” Study, funded by NHMRC of Australia. ACTRN12607000289415

CPAP MAS MAS CPAP WASHOUT 2 weeks BASELINE EVALUATION CPAP 4 weeks MAS 4 weeks END-POINT EVALUATION 1 MAS 4 weeks CPAP 4 weeks WASHOUT 2 weeks END-POINT EVALUATION 2 MAS CPAP CPAP MAS

“MASPAP” Study Design

Acclimatization

Phillips CL et al, AJRCCM 2013 (In Press)

Measurements

› 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 CPAP)

Baseline Characteristics

Variable (±SD) Entire Group Mild OSA 5≤AHI<15 Moderate OSA 15≤AHI<30 Severe OSA AHI≥30 Number Male / Female 126 102/24 23 15/8 69 56/13 34 31/3 Demographics / Anthropometry Age (yrs) 49.5±11.2 50.1±11 48.4±11.3 51.6±11.1 BMI (kg/m2) 29.5±5.5 28.3±6.3 29.3±5.7 30.6±4.6 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 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 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 Office BP SBP (mmHg) DBP (mmHg) 123.7±14.1 80.6±9.1 123±15.3 81.1±9.7 122.1±12.1 79.6±8.5 126.7±16.1 82.0±9.8 Medication Anti-Hypertensive 48 10 23 15 Anti-Diabetic 7 2 4 1

82% 38%

PSG Outcomes

Variable (Mean ± SE) Baseline CPAP MAS AHI (hr-1) 26.1±1.2 4.5±0.7** 11.1±1.2**‡ ODI 3% (hr-1) 21.4±1.3 5.6±1.0** 8.9±1.2**‡ Min SaO2 (%) 82±0.7 91±0.5** 87±0.6**‡ 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** 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

Treatment Compliance – Self Report

Mean CPAP use 5.1+2.0 hrs Mean MAS use 6.28+1.5 hrs

Summary of Results

› CPAP was superior to MAS in controlling OSA › Compliance with MAS was superior to CPAP (at least subjective) › MAS was non-inferior to CPAP in terms of impact on a range of health outcomes, including:

• Blood pressure outcomes (peripheral and central)
• Sleepiness
• Driving simulator performance
• Quality of life (MAS superior in some domains)

Phillips CL et al, AJRCCM 2013 (In Press)

Long-term Effectiveness

› 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 follow- up required

Marklund et al, Chest 2001

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)

Treatment Preference Acute Side Effects

› Compared to control:

• Jaw discomfort
• Tooth tenderness
• Excessive salivation

› Generally mild › Comparable to CPAP in terms of severity and frequency, albeit different profile

Gotsopoulos et al AJRCCM 2002 Gagnadouz et al, ERJ, 2009

1992 2001

Retroclination of the maxillary incisors Distal tipping of the maxillary molars Proclination of the mandibular incisors Mesial tipping of the mandibular molars

Long-Term Side Effects

1996 2001 1992

Courtesy: Prof Alan Lowe, University of British Columbia

Comparison of Treatment Performance: MAS vs CPAP

Health benefits Adherence Symptom control Tolerance Patient & partner acceptance Convenience Cost- effectiveness PSG efficacy CPAP MAS

Chan & Cistulli, Cur Opin Pulmon Med, 2009

?

AASM Practice Parameters 2005 “Although not as efficacious as CPAP, oral appliances are indicated for use in patients with mild to moderate OSA who prefer OAs to CPAP,

• r who do not respond to CPAP, are not

appropriate candidates for CPAP, or who fail treatment attempts with CPAP or treatment with behavioral measures such as weight loss or sleep position change.” (Guideline)

Kushida et al, Sleep, 2006

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) › Titration Protocol

• Initial advancement to 50-60% of maximum
• Incremental advancement over weeks or months
• Appropriate end-point of titration?

Single Night Titration of MAS

Dort et al, ERJ, 2006 Tsai et al. AJRCCM, 2004

› Identify responsiveness to MAS on single-night PSG › Analogous to CPAP titration › High PPV, and very good NPV › Identify target advancement

Contraindications

› 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

Predictors of Treatment Response

Anthropomorphic › Younger age › Female gender › Lower BMI › Smaller neck circumference › Smaller overjet Polysomnographic › Lower baseline AHI › Supine-dependent OSA › Oropharyngeal collapse

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

Awake Physiological Measures › Flow-volume loops (reduced MIF) › High nasal resistance Imaging › Nasopharyngoscopy (VP enlargement with MAS) › CT/MRI (VP enlargement with MAS) › Cephalometric (various)

Combination with other Therapy?

Weight loss Nasal decongestants Positional Therapy Provent Surgery CPAP Future Research

› Large scale multi-centre RCT of MAS vs CPAP › 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 MAS › Cost-effectiveness comparison