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
- Depression
- MDD
- Major Depressive Disorder
- Major Depressive Episode
Eligibility Criteria
- Sex
- ALL
- Age
- 24 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- 60Hz Intermittent Light Therapy — DEVICEIntermittent 60 Hz flickering white light delivered via a wearable headset.
- Sham Light Therapy — DEVICEConstant 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
- First listed
- Aug 8, 2025
- Start date
- Aug 18, 2025
- Status verified
- Jun 2026
- Primary completion
- Jan 1, 2027
- Completion
- Feb 1, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Active Home-Based Intermittent Light TherapyAdults 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 TherapyAdults 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
- Shayna Pehel929-455-5104
- Giuseppina Pilloni929-455-5317
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10017 | - |
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