Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

Veterans Affairs (VA) Boston Healthcare System

Status: Enrolling

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Device: Intraoral Suction

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05489562

1686683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Single Arm Mouthguard

Other group

Description:

Subjects wearing mouthguard to access tolerability and comfort of the device

Treatment:

Device: Intraoral Suction