Recruiting

Intraoral Suction

Sponsor:

VA Boston Healthcare System

Code:

NCT05489562

Conditions

Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intraoral Suction

Study Details

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.

Conditions

Obstructive Sleep Apnea of Adult

Study ID

NCT05489562

Start date

Sep 25, 2023

Status verified date

Oct, 2023

Completion date

Oct, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Single Arm Mouthguard

Subjects wearing mouthguard to access tolerability and comfort of the device

Interventions

Intraoral Suction

stabilization of the tongue using intraoral suctioning and its effects on sleep parameters in patients with obstructive sleep apnea (OSA).

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

VA Boston Healthcare System

Recruiting

Jamaica Plain, Massachusetts, United States, 02130

Contacts

More Information

Sponsor

VA Boston Healthcare System

Last update posted

Oct 12, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Boston Healthcare System on 2023-10-12.