Trial Summary
What is the purpose of this trial?Obstructive sleep apnea (OSA) is a sleep disorder that is commonly treated using positive airway pressure, yet 50% of patients still experience residual sleepiness after successful therapy. A potential neuromodulation strategy that can decrease residual sleepiness is transcranial photobiomodulation (tPBM). tPBM is a neuromodulatory treatment that uses red and/or near infrared light to penetrate the cortex and can alter both cerebral metabolism and blood flow. However, this potential has never been explored before directly in sleep disordered individuals. This project aims to explore the effect of tPBM on sleepiness and understand the potential neural mechanism of tPBM in OSA. The short-term goal of this project is to collect pilot data, which is the first of its kind, and suggest tPBM as a potential modulator of sleepiness in OSA.
Eligibility Criteria
This trial is for individuals with Obstructive Sleep Apnea (OSA) who still feel very sleepy during the day even after using standard treatments. Participants should be those looking to try a new therapy involving light to potentially improve wakefulness.Inclusion Criteria
I have been treated for sleep apnea for over a year and my condition is under control.
Cognitively normal (Telephone Interview for Cognitive Status (TiCS) score ≥29)
I have been diagnosed with moderate to severe sleep apnea in the last year.
+2 more
Exclusion Criteria
Other sleep-related breathing disorders based on American Academy of Sleep Medicine (AASM) criteria
Chronic regular use of stimulant if unable to complete a washout prior to MRI
I have been diagnosed with chronic insomnia or trouble falling asleep.
+18 more
Participant Groups
The study is testing transcranial photobiomodulation (tPBM), which uses specific types of light on the brain, as a treatment to reduce sleepiness in people with OSA. It's an early-stage trial aiming to gather initial data on tPBM's effectiveness and how it works.
1Treatment groups
Experimental Treatment
Group I: Participants with Moderate-to-Severe OSAExperimental Treatment1 Intervention
Participants will receive tPBM treatment for approximately 12 minutes and complete assessments. Participants have the choice to participate in an optional follow-up 1 week post-initial visit, in which they will receive tPBM treatment for approximately 11-12 minutes and complete assessments at a different time of day.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
American Academy of Sleep Medicine FoundationCollaborator
American Academy of Sleep MedicineCollaborator