Using a mouth guard to help prevent sleep apnea
Official title: Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial
Run by Queen Mary University of London · NCT04092660 · Data updated 2026-11-12
This study is testing if a special mouth guard can help people with sleep apnea breathe better at night and if extra support can encourage them to use it more often.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 90 Years |
| Sex | All |
| Enrollment | 56 (estimated) |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | December 6, 2019 |
| Main results expected | June 1, 2026 |
| Study ends | June 1, 2026 |
| Registry record updated | May 6, 2026 |
| Trial ID | NCT04092660 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 40 and older with a confirmed diagnosis of obstructive sleep apnea who are referred for MAA therapy.
✕Probably not a fit
Patients with insufficient teeth for MAA fabrication, poor dental health, symptomatic temporomandibular disorder, or a history of epilepsy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a Mandibular Advancement Appliance (MAA) in patients with Obstructive Sleep Apnea (OSA) and whether additional support interventions can increase its usage compared to standard care. Participants aged 40 and older with a confirmed diagnosis of OSA will be randomly assigned to either an intervention group, receiving extra support and education, or a control group receiving standard care. The study will also explore factors influencing patients' adherence to using the MAA, including psychological and social aspects. Data on usage will be collected through sleep diaries and sensors in the appliance.
Why it matters
Potential benefit: If successful, this study could lead to improved adherence to MAA therapy, enhancing treatment outcomes for patients with obstructive sleep apnea.
How similar studies have gone: Previous studies have shown that behavioral interventions can improve adherence to treatment in similar patient populations, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥ 40 years old) * Confirmed diagnosis of OSA (AHI ≥ 5) * Referred for MAA therapy * Must be able to understand, read and write English; with the assistance of a translator Exclusion Criteria: * Insufficient teeth for MAA fabrication * Poor dental and/or periodontal health * Symptomatic Temporomandibular Disorder (TMD) * Previously used an MAA * Patients with Epilepsy
Where it's running
-
Royal London Dental Hospital
London, United Kingdom Recruiting
Study contacts
- Study coordinator: Ama Johal
- Email: a.s.johal@qmul.ac.uk
- Phone: 0207 377 7686
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.