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

NCT06960200 | Recruiting Phase 2

• 1 other identifier: Pro00125341
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• OSA disease index

  4 months

Study Arms (3)

Control

NO INTERVENTION

NL C3

EXPERIMENTAL

Device: Phototherapy

QN

EXPERIMENTAL

Device: Phototherapy

Interventions

Phototherapy DEVICE

Non-surgical laser therapy (phototherapy)

NL C3; QN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with OSA
• incomplete treatment with OAT/MAD

You may not qualify if:

• not diagnosed with OSA
• using CPAP

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta, Edmonton, Alberta T6G 2E1

Edmonton, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Enoch Ng

CONTACT

780-407-5550; enoch@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 7, 2025
• Study Start: January 5, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)