Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

October 10, 2023 updated by: Ravi Rasalingam, MD, VA Boston Healthcare System
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients who are newly diagnosed with moderate OSA or diagnosed with OSA in the past 5 years and who are not compliant with continuous positive airway pressure treatment will be identified from the Boston VA Healthcare Sleep Laboratory database and invited to participate in the study. Those patients interested in participating will be consented and then evaluated for adequate nasal patency and oral dentition to assess their eligibility for the study. This is a pilot study primarily assessing tolerability of using intraoral suction to stabilise the tongue at night as well as its effects on sleep parameters. Target enrollment is 40 patients. Those enrolled will have a digital intra-oral scan performed and a custom-fit mouthguard that can transmit low level intermittent suction fabricated. The participant will wear this mouthguard for up to five consecutive nights. They will complete a survey designed to assess tolerability following five nights of wearing the mouthguard. The participant will then have a two night in-hospital polysomnography performed one night with the mouthguard transmitting suction and a second night with no suction. The outcomes will be measured using the tolerability survey scores and the duration and quality of sleep as measured by polysomnography.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Jamaica Plain, Massachusetts, United States, 02130
        • Recruiting
        • VA Boston Healthcare System
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm Mouthguard
Subjects wearing mouthguard to access tolerability and comfort of the device
Device: Intraoral Suction
stabilization of the tongue using intraoral suctioning and its effects on sleep parameters in patients with obstructive sleep apnea (OSA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients reporting adverse events related to use of intraoral suction to stabilize the tongue as assessed by a survey
Time Frame: Up to 16 weeks
Tolerability and comfort will be assessed by a survey completed by each study subject. Number of patients reporting moderate or more severe pain related to use of intraoral suction to stabilize the tongue as assessed by a self-reported survey using a 5-point pain scale. The survey will be completed by each study subject after having worn the mouthguard for up to 5 consecutive nights in a row. Moderate to severe pain is classified as a score of 3 or higher.after their having worn the mouthguard for up to 5 consecutive nights in a row
Up to 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on sleep duration
Time Frame: Up to 16 Weeks
Change in sleep duration (minutes) with and without intraoral suction as measured by polysomnography
Up to 16 Weeks
Effect on sleep quality
Time Frame: Up to 16 Weeks
Change in percentage time in rapid eye movement (REM) with and without intraoral suction as measured by polysomnography
Up to 16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Boston Healthcare System

Collaborators

Massachusetts Institute of Technology

Investigators

  • Principal Investigator: Ravi Rasalingam, MD, VA Boston Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1686683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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