Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNYU Langone Health

About 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

Qualifiers

Cognitively normal (Telephone Interview for Cognitive Status (TiCS) ≥29))

Moderate - severe OSA

Currently on therapy for OSA and has received treatment for OSA for at least 3 months.

Sustained compliance with continuous positive airway pressure (CPAP), which means using the machine at least 4 hours per night for five nights a week.

Disqualifiers

Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index (ISI)

Documented diagnosis of circadian rhythm disorder

Any current use of supplemental oxygen

Other sleep-related breathing disorders (central sleep apnea, etc.) based on American Academy of Sleep Medicine (AASM) criteria

Trial design

Treatments tested in this trial

  • Active tPBM

Treatment groups

22 Participants
are divided into 1 treatment group

Sponsors and collaborators

NYU Langone Health

Lead sponsor

American Academy of Sleep Medicine

Collaborator