Intraoral Suction for Obstructive Sleep Apnea

Recruiting in Palo Alto (17 mi)

Overseen byRavi Rasalingam, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Boston Healthcare System

No Placebo Group

Trial Summary

What is the purpose of this trial?To learn whether stabilization of the tongue using intraoral suction is tolerable and what effects this approach has on sleep parameters in obstructive sleep apnea.

Eligibility Criteria

This trial is for adults aged 18-80 with moderate to severe obstructive sleep apnea diagnosed within the last 5 years, who struggle to use their positive airway pressure devices regularly. Participants should have good teeth to support a dental retainer and a BMI of 40 or less. Those with central sleep apnea, other sleep disorders, immune deficiencies, prior OSA surgery, nasal obstructions, certain medication use or substance abuse are excluded.

Inclusion Criteria

You have a moderate to severe sleep disorder with a certain measurement called AHI, REI, or RDI.

I was diagnosed with a sleep disorder over 6 months ago but less than 5 years, and I haven't been using my treatment device as recommended.

I am between 18 and 80 years old.

+3 more

Exclusion Criteria

I use a mouth device for sleep apnea treatment.

I have had blockages in my nose due to its structure.

I have had surgery for sleep apnea.

+6 more

Participant Groups

The study tests if using intraoral suction can help people with obstructive sleep apnea by stabilizing the tongue during sleep. It aims to see if this method is comfortable for patients and how it affects their sleep quality.

1Treatment groups

Experimental Treatment

Group I: Single Arm MouthguardExperimental Treatment1 Intervention

Subjects wearing mouthguard to access tolerability and comfort of the device