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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07111390
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
24 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 60Hz Intermittent Light Therapy — DEVICE
    Intermittent 60 Hz flickering white light delivered via a wearable headset.
  • Sham Light Therapy — DEVICE
    Constant white light delivered via a wearable headset.

Study Details

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.

Key Dates

Start date
Aug 18, 2025
Status verified
Aug 2025
Primary completion
Feb 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Home-Based Intermittent Light Therapy
    Adults with a major depressive episode (MDE) randomized to receive active home-based 60Hz intermittent light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions.
  • Sham Comparator: Sham Home-Based Light Therapy
    Adults with a major depressive episode (MDE) randomized to receive sham home-based light therapy, delivered five days per week for three weeks for a total of 15x30-minute daily sessions.

Primary Outcome Measure

Proportion of Participants who Complete all Scheduled Sessions [ Time Frame: Up to Week 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10017-

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