Using a mouth guard to help prevent sleep apnea
Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT04092660 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of obstructive sleep apnea who are referred for MAA therapy.
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.
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 performed: Previous studies have shown that behavioral interventions can improve adherence to treatment in similar patient populations, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
London
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.