Recruiting
Phase 2

Phototherapy & OAT

Sponsor:

University of Alberta

Code:

NCT06960200

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Phototherapy

Study Details

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

Study ID

NCT06960200

Start date

Jan 5, 2024

Status verified date

May, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • diagnosed with OSA
  • incomplete treatment with OAT/MAD

Exclusion Criteria:

  • not diagnosed with OSA
  • using CPAP

Study Design

Enrollment

528 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

experimental: NL C3

experimental: QN

Interventions

Phototherapy

Non-surgical laser therapy (phototherapy)

Primary outcome measure

  • OSA disease index [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

University of Alberta, Edmonton, Alberta T6G 2E1

Recruiting

Edmonton, Canada

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Jun 1, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-01.