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RECRUITING
NCT06960200
PHASE2

Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep Apnea

Sponsor: University of Alberta

View on ClinicalTrials.gov

Summary

Obstructive sleep apnea (OSA) is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. However, while the majority of OSA patients are able to tolerate the use of oral appliance therapy (OAT) for OSA, some patients are incomplete responders to OAT. These patients, despite having improvement, may still have a disease index above the diagnostic threshold for OSA. Phototherapy (laser therapy) has been used as a method to stiffen the soft palate and parts of the tongue to prevent their collapse. This is a type of cold laser therapy that does not cut/ablate tissue (similar to healing laser therapies). This has been shown to help with both snoring and can also help with OSA, as soft palate and tongue collapse are common areas for where OSA occurs inside the airway. A recent pilot study has shown that phototherapy on its own may be able to treat selected patients with mild, moderate, or severe OSA. To our knowledge, there are no contraindications to combining phototherapy and dental sleep appliance therapy.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

528

Start Date

2024-01-05

Completion Date

2030-12

Last Updated

2025-05-07

Healthy Volunteers

Yes

Interventions

DEVICE

Phototherapy

Non-surgical laser therapy (phototherapy)

Locations (1)

University of Alberta, Edmonton, Alberta T6G 2E1

Edmonton, Canada