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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 16 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 16 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of patients reporting adverse events related to use of intraoral suction to stabilize the tongue as assessed by a survey

Secondary outcome measures

Effect on sleep duration

Effect on sleep quality

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Arm MouthguardExperimental Treatment1 Intervention

Subjects wearing mouthguard to access tolerability and comfort of the device

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Boston Healthcare SystemLead Sponsor

68 Previous Clinical Trials

970,412 Total Patients Enrolled

Massachusetts Institute of TechnologyOTHER

97 Previous Clinical Trials

12,729,947 Total Patients Enrolled

Ravi Rasalingam, MDPrincipal InvestigatorVA Boston Healthcare System

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unoccupied positions available for potential participants of this trial?

"Reports on clinicaltrials.gov suggest that enrollment for this medical trial is still open, with the original posting dating back to September 25th 2023 and a recent edit being done on October 10th 2023."

Answered by AI

Is geriatric participation accepted for this experiment?

"Applicants aged 18 to 80 are eligible for this study. Meanwhile, there is a separate pool of 43 trials available for minors and 221 studies accessible to those above the age 65 threshold."

Answered by AI

What is the total number of participants currently enrolled in this research?

"Affirmative. Clinicaltrials.gov has verified that this clinical trial, which premiered on September 25th 2023, is actively recruiting patients. 40 volunteers are required to participate at one medical centre."

Answered by AI

What demographic is best suited to enroll in this research program?

"This medical trial is accepting 40 participants between the ages of 18 and 80 who have been diagnosed with obstructive sleep apnea. To qualify, candidates must be between 18-75 years old, possess an Apnea Hypopnea Index in the moderate range (15-30), maintain a Body Mass Index under 40, use Continuous Positive Airway Pressure machines but not consistently comply to their usage rules (<4 hours/night for 5 nights per week) while still using it within one month prior to enrollment, plus hold adequate dentition that will allow them to wear dental retainers."

Answered by AI

Recent research and studies

American Journal of EpidemiologyJournal

Increased Prevalence of Sleep-disordered Breathing in Adults

Peppard, P. E., T. Young, J. H. Barnet, M. Palta, E. W. Hagen, and K. M. Hla. 2013. “Increased Prevalence of Sleep-disordered Breathing in Adults”. American Journal of Epidemiology. Oxford University Press (OUP). doi:10.1093/aje/kws342.

clinicaltrials.govStudy

Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

Ravi Rasalingam, MD 2023. "Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05489562.

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