Mandibular advancement splint in obstructive sleep apnea assessed by IQWiG in Germany

The Institute for Quality and Efficiency in Health Care (IQWiG) published the final report, in which it was studied whether wearing a lower jaw protrusion splint (Unterkieferprotrusionsschiene, UPS) is beneficial for obstructive sleep apnea. IQWiG issued the preliminary report in October 2019.

Obstructive sleep apnea occurs when the upper respiratory tract muscles relax. Sleep apnea leads to sleep fragmentation and, thus, often to a not restful sleep. Consequently, exhaustion, daytime sleepiness, involuntary falling asleep, loss of cognitive performance, and increased accident frequency occur, among other things. Untreated obstructive sleep apnea is associated with increased blood pressure, cardiovascular events such as heart attack and stroke, and increased mortality.

For mild sleep apnea, conservative measures such as weight loss, sleep hygiene measures (no alcohol, no smoking), or postural therapy (avoidance of supine sleep) may be sufficient. For a higher severity, positive airway pressure via a mask (PAP therapy) is the standard treatment. In this case, the airways are kept open by positive pressure ventilation.

Mild to moderate obstructive sleep apnea can also be treated with the help of a UPS worn during sleep. The plastic splint in the mouth, adapted by a dentist or an orthodontist, ensures that the lower jaw is held further forward. As a result, the airways are kept mechanically open. This method is usually well-tolerated and often preferred by patients to PAP therapy. It is generally used in severe obstructive sleep apnea only in case of intolerance or intolerance of PAP therapy.

A systematic literature search was carried out in the databases MEDLINE, Embase, and Cochrane Central Register of Controlled Trials. At the same time, relevant systematic overviews were searched in the databases MEDLINE, Embase, Cochrane Database of Systematic Reviews, and HTA Database.

The IQWiG examined two questions:

1. Does treatment with a UPS provide any benefit or harm compared to no treatment or placebo treatment?
2. Does treatment with a UPS provide any benefit or harm compared to treatment with positive airway pressure via a mask (PAP therapy)?

The research identified 37 randomized controlled studies as relevant for the benefit assessment. A total of eight ongoing and two planned studies were identified.

Results (question 1):

• Sleep quality: there was a statistically significant difference for the following components according to Pittsburgh Sleep Quality Index (PSQI): sleep duration (component 1) (mean difference (MD): −0.20; 95% CI: [−1.77; 1.37]; p = 0.796), sleep efficiency (component 5) (MD: 0,1; 95 %- CI: [−1,02; 1,22]; p = 0,857), as well as for fatigue on awakening (MD: 0.58; 95% CI: [−0.11; 1.27]; p = 0.094). Overall, there was a statistically significant and clinically relevant difference in favor of treatment with UPS compared to no treatment or placebo treatment (OR: 3,53; 95 %-CI: [1,37; 9,10]; p = 0,008)
• Paced Auditory Serial Addition Task (PASAT) as an assessment of executive functions: in the single analysis of the Barnes study 2004 for the PASAT with the interstimulus interval of 1.2 seconds, there was a statistically significant and clinically relevant difference in favor of the UPS (MD [95% CI], p-value: -0.80; 1.01; -0.59]; <0.001; Hedges' g [95 %-KI: [−1,33; −0,69])
• Fatigue: there was a statistically significant and clinically relevant difference (OR: 8,14; 95 %-KI: [2,29; 28,90]; p < 0,001) for the comparison between UPS versus placebo treatment
• There was either no statistically significant and/or no clinically relevant difference found in the joint evaluation of the studies with moderate and high qualitative reliability of results regarding overall mortality or overall survival, the effect of the UPS compared to PAP-therapy in the assessment using the Epworth Sleepiness Scale (ESS), daytime sleepiness, regarding cognitive performance (vigilance, reaction time, executive functions – except for the PASAT assessment results), symptoms of depression and fear, mental symptoms, somatic symptoms – headache, cardiovascular morbidity, fatigue (according to the Modified Fatigue Impact Scale assessment), health-related quality of life (according to 36-Item Short-Form Health Survey (SF-36) assessment), functional outcomes of sleep questionnaire (FOSQ), participation in professional and social life, serious adverse events and discontinuations due to adverse events, Apnea-Hypopnea Index (AHI) and oxygen desaturation index (ODI)

Results (question 2):

• Daytime sleepiness - Berlin Questionnaire for Sleep Apnea: Single question about daytime tiredness: there was a statistically significant difference in favor of PAP therapy (MWD [95% CI]; p-value: -0.5 [-0.82; -0.18]; 0.003)
• Health-related quality of life: the individual evaluation for Nottingham Health Profile (NHP)-subscore “sleep” revealed a statistically significant difference (MWD [95% CI]; p-value: -10.30 [-19.65; -0.95]; 0.031)
• There was no statistically significant difference found in the joint evaluation of the studies with moderate and high qualitative reliability of results regarding overall mortality or overall survival, daytime sleepiness, the effect of the UPS compared to PAP-therapy in the assessment using the Epworth Sleepiness Scale (ESS), quality of sleep, regarding cognitive performance (vigilance, executive functions), symptoms of depression and fear, mental symptoms, somatic symptoms, cardiovascular morbidity, health-related quality of life (according to 36-Item Short-Form Health Survey (SF-36) assessment), daily life and participation in professional and social life, serious adverse events and discontinuations due to adverse events, AHI and ODI

As a conclusion, IQWiG stated that using a UPS, daytime sleepiness can be alleviated in patients with obstructive sleep apnea. Therapy with a UPS is not inferior to PAP therapy with a sleep mask.

The final report in German can be found here. The preliminary report can be found here.

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