Clinical trial Recruiting at 1 site Interventional Ages 40 to 90

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 typeInterventional
Ages40 Years to 90 Years
SexAll
Enrollment56 (estimated)
SponsorQueen Mary University of London
Academic / other
Locations1 site (London)
StatusRecruiting
StartedDecember 6, 2019
Main results expectedJune 1, 2026
Study endsJune 1, 2026
Registry record updatedMay 6, 2026
Trial IDNCT04092660 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.