NCT07111390

Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)

A Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for the Treatment of Depression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 24 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This pilot study evaluates the feasibility, safety, and preliminary efficacy of home-based 60Hz intermittent light therapy in adults with a major depressive episode (MDE). Participants will be randomized in a 2:1 ratio to receive either active or sham 60Hz intermittent light stimulation for 30 minutes daily (Monday through Friday) over three weeks. The light is delivered through a wearable headset. Clinical assessments will be conducted remotely at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms.

Detailed description

This pilot study will evaluate the tolerability, usability, and preliminary impact of a novel wearable device delivering 60Hz intermittent light for treatment of depressive symptoms in adults with MDD. All procedures are conducted remotely.

Conditions

• Depression
• MDD
• Major Depressive Disorder
• Major Depressive Episode

Interventions

Type	Name	Description
DEVICE	60Hz Intermittent Light Therapy	Intermittent 60 Hz flickering white light delivered via a wearable headset.
DEVICE	Sham Light Therapy	Constant white light delivered via a wearable headset.

Timeline

• Start date: 2025-08-18
• Primary completion: 2026-02-01
• Completion: 2026-03-01
• First posted: 2025-08-08
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study