Using laser therapy to improve treatment for obstructive sleep apnea
Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep Apnea
This study is testing if a cold laser therapy can help people with obstructive sleep apnea who haven't had enough success with their oral appliances feel better and breathe easier while they sleep.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 528 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton) |
| Trial ID | NCT06960200 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of phototherapy, specifically a cold laser technique, in enhancing the response of patients with obstructive sleep apnea (OSA) who have not fully benefited from oral appliance therapy (OAT). The goal is to determine if this adjunctive treatment can convert incomplete responders into complete responders by significantly reducing their apnea-hypopnea index. Participants will undergo assessments including digital impressions and imaging to evaluate the impact of the therapy on their condition. The study aims to provide a non-invasive alternative for patients who struggle with standard treatments.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with obstructive sleep apnea who have not achieved satisfactory results from oral appliance therapy.
Not a fit: Patients who are not diagnosed with obstructive sleep apnea or those currently using CPAP will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a more effective treatment option for patients with obstructive sleep apnea who do not respond adequately to oral appliance therapy.
How similar studies have performed: While phototherapy for OSA is a relatively novel approach, preliminary evidence suggests potential benefits, though further validation is needed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed with OSA * incomplete treatment with OAT/MAD Exclusion Criteria: * not diagnosed with OSA * using CPAP
Where this trial is running
Edmonton
- University of Alberta, Edmonton, Alberta T6G 2E1 — Edmonton, Canada (Recruiting)
Study contacts
- Study coordinator: Enoch Ng
- Email: enoch@ualberta.ca
- Phone: 780-407-5550
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.