Clinical trial NCT06960200: Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep Apnea
Official title: Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 528
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The purpose of this study is to determine whether phototherapy (nightlase/quiet night laser protocol) can change oral appliance therapy (OAT) incomplete responders into complete responders for the treatment of obstructive sleep apnea (OSA). Patients who are incomplete responders to OAT will become complete responders (as defined as a reduction of 50% and below 10) with the adjunctive use of phototherapy for OSA. Per the American Academy of Sleep Medicine, first line treatment for OSA is CPAP. Patients who are unable to tolerate CPAP or otherwise decline CPAP may be treated through OAT. However, which compliance with OAT is significantly greater than CPAP, overall efficacy of OAT is not as high as CPAP. Further treatment options for patients with are incomplete responders to OAT are limited (other options include surgical interventions such as bariatric surgery and/or jaw surgery). The use of phototherapy for OAT incomplete responders offers the possibility of changing the response pattern for these patients into complete response which may provide more complete treatment rather than partial management for their OSA. Data to be collected for this study will be standard data collected for dental sleep appliance therapy. This includes mandibular position (in digital impression form and as OJ and OB recordings), range of motion, side effects/adverse reactions, titrations (% and number), total time required for treatment, medical history, CBCT imaging, biographical data, phototherapy exposure settings, etc.

Eligibility criteria: Inclusion Criteria:

* diagnosed with OSA
* incomplete treatment with OAT/MAD

Exclusion Criteria:

* not diagnosed with OSA
* using CPAP

Primary outcomes:
measure: OSA disease index
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta, Edmonton, Alberta T6G 2E1
Study officials:
References: