Examining the effect of silicone mouth tape on snoring and mild sleep apnea
Mouth Tape for Snoring and Sleep Apnea (MTASSA)
This study tests if using silicone mouth tape at night can help adults with snoring and mild sleep apnea breathe better and sleep more soundly.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06587256 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of silicone mouth tape on reducing snoring and mild obstructive sleep apnea. It aims to promote nasal breathing during sleep, which may help alleviate the vibrations causing snoring and improve overall sleep quality. Participants will include adults with a history of snoring and mild sleep apnea, and they will be monitored for changes in their snoring patterns and sleep quality. The study will utilize a controlled intervention approach, comparing outcomes before and after the use of mouth tape.
Who should consider this trial
Good fit: Ideal candidates are adults with a body mass index of 35 kg/m2 or higher, who have a self-reported history of snoring and a prior sleep study indicating no sleep apnea or mild sleep apnea.
Not a fit: Patients with chronic lung disease, significant tonsil enlargement, or those who cannot tolerate nasal breathing with mouth tape will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could provide a non-invasive solution for patients suffering from snoring and mild sleep apnea, improving their sleep quality and overall health.
How similar studies have performed: While the use of mouth tape for snoring is a relatively novel approach, existing studies have shown that promoting nasal breathing can reduce snoring, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with a body mass index of 35 kg/m2 with a self-reported history of snoring and a bed partner who can provider answers to about the patients snoring. Patients must have a prior sleep study that shows no sleep apnea, or mild sleep apnea (AHI under 15 events/hr). Exclusion Criteria: * Allergy to silicone mouth tape, chronic lung disease, facial hair preventing wearing of the tape * Grade 3+ or 4+ tonsils, prior palatal or tongue surgery. * Patients may not have any form of chronic or acute hypoventilation. * Patients must be able to tolerate breathing through their nose with the mouth tape in place for at least 3 minutes. * Patients may not be pregnant
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Jun, MD — Johns Hopkins University
- Study coordinator: Mariah Potocki Study Coordinator
- Email: mchaney7@jhmi.edu
- Phone: 410-550-2233
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.