NCT05489562

Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: VA Boston Healthcare System · Federal
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
DEVICE	Intraoral Suction	stabilization of the tongue using intraoral suctioning and its effects on sleep parameters in patients with obstructive sleep apnea (OSA).

Timeline

• Start date: 2023-09-25
• Primary completion: 2024-07-01
• Completion: 2024-10-01
• First posted: 2022-08-05
• Last updated: 2023-10-12

Locations

1 site across 1 country: United States