NCT06960200 Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep Apnea
| NCT ID | NCT06960200 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Alberta |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 528 participants |
| Start Date | 2024-01-05 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 528 participants in total. It began in 2024-01-05 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * diagnosed with OSA * incomplete treatment with OAT/MAD Exclusion Criteria: * not diagnosed with OSA * using CPAP
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06960200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06960200 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06960200 currently recruiting?
Yes, NCT06960200 is actively recruiting participants. Contact the research team at enoch@ualberta.ca for enrollment information.
Where is the NCT06960200 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT06960200 clinical trial?
NCT06960200 is sponsored by University of Alberta. The trial plans to enroll 528 participants.