Using intraoral suction to stabilize the tongue for obstructive sleep apnea
Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea
This study is testing if a special mouthguard that uses gentle suction to hold the tongue in place can help people with obstructive sleep apnea sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | VA Boston Healthcare System Federal |
| Locations | 1 site (Jamaica Plain, Massachusetts) |
| Trial ID | NCT05489562 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the tolerability and effects of using intraoral suction to stabilize the tongue in patients with obstructive sleep apnea (OSA). Participants will be recruited from the Boston VA Healthcare Sleep Laboratory and must meet specific eligibility criteria, including being newly diagnosed or non-compliant with CPAP treatment. After consenting, participants will receive a custom-fit mouthguard that transmits low-level suction and will wear it for five consecutive nights. The study will assess tolerability through surveys and measure sleep quality using polysomnography over two nights, comparing results with and without suction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with moderate to severe obstructive sleep apnea who are either newly diagnosed or non-compliant with CPAP treatment.
Not a fit: Patients with central sleep apnea, other sleep disorders, or those currently using other oral appliances for OSA may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new, non-invasive treatment option for patients with obstructive sleep apnea who struggle with traditional CPAP therapy.
How similar studies have performed: While the use of intraoral devices for OSA is not novel, the specific application of intraoral suction is relatively untested, making this approach innovative.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age 18-80 Patients newly diagnosed with OSA (a diagnosis of OSA ≤6 months) who may or may not have started using their PAP yet Patients diagnosed \> 6 months but within the past 5 years who are not compliant with positive airway pressure treatment. Non compliance is defined as use of device for an average of \<4 hours/night OR \< 5 nights/week An AHI, REI or RDI or any synonymous term for AHI in the moderate to severe range (15-60) A body mass index (BMI) less than \<=40 (BMI within 1 year of enrollment date) Adequate dentition to support a dental retainer Exclusion Criteria: Evidence of central sleep apnea or concomitant sleep disorder other than OSA Currently using MAD or other form of mouth prosthesis to treat OSA Prior surgical treatment for OSA History of anatomic nasal obstruction Use of medications that may affect sleep (hypnotic medications for the treatment of insomnia) Use of pacemaker or implantable cardioverter-defibrillator (ICD) Immunocompromised (i.e., susceptible to infection) Open soars/wounds in patient's mouth Active alcohol abuse or IV drug use
Where this trial is running
Jamaica Plain, Massachusetts
- VA Boston Healthcare System — Jamaica Plain, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ravi Rasalingam, MD — VA Boston Healthcare System
- Study coordinator: Ravi Rasalingam, MD
- Email: ravi.rasalingam@va.gov
- Phone: 857-203-6840
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.