Obstructive Sleep Apnea Clinical Trials

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Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness (STILL TIRED)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• Epworth Sleepiness Score (ESS) greater than or equal to 8 or excess daytime sleepiness as defined by the Functional Outcome Sleep Questionnaire or clinical complaint.

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Naomi Gaggi
Naomi.Gaggi@nyulangone.org
(646) 754-2238
Backup
Jennifer Bernal
Jennifer.Bernal@nyulangone.org
(646) 754-2238
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2026-10-03
Participants
Target number of participants: 22
Treatments
Experimental: Participants with Moderate-to-Severe OSA
Participants will receive tPBM treatment and sham 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.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: American Academy of Sleep Medicine

This content was sourced from clinicaltrials.gov