Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

Status unconfirmed · Not applicable

Conditions studied: Obstructive Sleep Apnea of Adult

In brief

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.

Key facts

Study ID

NCT05489562

Run by

VA Boston Healthcare System

People needed

40

Starts

2023-09-25

Expected to finish

2024-10-01

Last updated by the study team

2023-10-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Boston Healthcare System — Jamaica Plain, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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