Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea of Adult
• Interventions: Device: Intraoral Suction

• Registration Number: NCT05489562
• Lead Sponsor: VA Boston Healthcare System

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Study Start: 2023-09-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-12
• Primary Completion: 2024-07
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Mouthguard	Intraoral Suction	Subjects wearing mouthguard to access tolerability and comfort of the device

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Boston Healthcare System; 🇺🇸 Jamaica Plain, Massachusetts, United States