NCT06698809

Obstructive Sleep Apnea Therapeutic Intervention for REsiDual Sleepiness

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea
• Sleepiness

Interventions

Type	Name	Description
DEVICE	Active 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. Subjects will receive treatment for approximately 12 minutes per treatment and sham.

Timeline

• Start date: 2026-01-12
• Primary completion: 2026-09-01
• Completion: 2026-10-03
• First posted: 2024-11-21
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study