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Intraoral Suction for Obstructive Sleep Apnea

N/A
Recruiting
Led By Ravi Rasalingam, MD
Research Sponsored by VA Boston Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80
Adequate dentition to support a dental retainer
Must not have
Currently using MAD or other form of mouth prosthesis to treat OSA
History of anatomic nasal obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new method to treat obstructive sleep apnea: stabilizing the tongue using suction inside the mouth.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort in the mouth from the device used for intraoral suction or irritation where it contacts oral tissues. There might also be an increased risk of oral infections due to prolonged device usage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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My teeth can support a dental retainer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use a mouth device for sleep apnea treatment.
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I have had blockages in my nose due to its structure.
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I have had surgery for sleep apnea.
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I am at high risk for infections.
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I have open sores in my mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients reporting adverse events related to use of intraoral suction to stabilize the tongue as assessed by a survey
Secondary study objectives
Effect on sleep duration
Effect on sleep quality

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm MouthguardExperimental Treatment1 Intervention
Subjects wearing mouthguard to access tolerability and comfort of the device

Find a Location

Who is running the clinical trial?

VA Boston Healthcare SystemLead Sponsor
70 Previous Clinical Trials
970,518 Total Patients Enrolled
Massachusetts Institute of TechnologyOTHER
98 Previous Clinical Trials
12,819,947 Total Patients Enrolled
Ravi Rasalingam, MDPrincipal InvestigatorVA Boston Healthcare System
~19 spots leftby Nov 2025
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