Actively Recruiting
Feasibility Pilot Study of Home-Based Intermittent 60Hz Light Therapy for Treating Depression
Led by NYU Langone Health · Updated on 2025-08-26
40
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
S
Syntropic Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility, safety, and early effects of a home-based intermittent light therapy using a wearable headset in adults experiencing a major depressive episode (MDE). This pilot study focuses on adults aged 24 to 65 years diagnosed with major depressive disorder (MDD). The study aims to understand whether this novel 60Hz flickering light therapy is tolerable and usable for patients with depression, with all procedures conducted remotely. Participants are randomly assigned in a 2:1 ratio to receive either the active 60Hz intermittent light therapy or a sham light therapy, both delivered through a wearable headset. Each participant completes 30-minute daily sessions, Monday through Friday, for three weeks, totaling 15 sessions. The active therapy uses flickering white light, while the sham therapy uses constant white light, allowing comparison of effects between these two interventions. Throughout the study, participants undergo remote clinical assessments at the start, mid-point, end of treatment, and follow-up to track changes in depressive symptoms using several rating scales. Researchers will monitor session completion rates, adverse effects, and usability of the device. The primary outcomes include the proportion of participants completing all sessions and those discontinuing due to side effects. The study lasts three weeks, with evaluations focused on symptom changes and safety.
CONDITIONS
Brief Title
Feasibility of Home-Based Intermittent 60Hz Light Therapy for Major Depressive Disorder (MDD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 24 and 65 years inclusive
- Confirmed diagnosis of Major Depressive Disorder (MDD) based on MINI interview
- Hamilton Depression Rating Scale (HDRS-17) score 17 or higher at screening
- Stable antidepressant medication dose for at least 30 days before screening
- No premorbid cognitive impairment (WRAT-5 Reading Recognition Subtest score above 85)
- Access to a local healthcare provider responsible for clinical care and available if risk increases
- Able to provide informed consent and follow study procedures
- Access to a quiet space suitable for home-based light therapy sessions
- English speaking since all materials and assessments are validated only in English
You will not qualify if you...
- Primary neurological or autoimmune disorders
- Psychiatric comorbidities such as anxiety disorders, OCD, PTSD, bipolar disorder, or psychotic disorders
- Current or recent alcohol or substance use disorder
- History of bipolar disorder or any psychotic disorder
- Significant suicidal thoughts or behavior based on clinical judgment and Columbia-Suicide Severity Rating Scale
- History of seizure disorder or epilepsy
- History of migraine, tinnitus, or photosensitivity
- Retinal disease, cataract, or visual impairments interfering with light exposure
- Regular use of anti-inflammatory drugs or anticoagulants like clopidogrel
- Currently pregnant, planning pregnancy during the study, or breastfeeding
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote)
Duration - 3 weeks
Participants receive home-based light therapy sessions using a wearable headset delivering either active 60Hz intermittent light or sham constant light. Sessions occur five days per week for three weeks with each session lasting 30 minutes.
15 remote sessions (5 sessions per week)
Duration - Up to 1 week after treatment
Participants complete usability and outcome assessments remotely after completing the treatment sessions.
1 remote follow-up assessment
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
Research Team
S
Shayna Pehel
G
Giuseppina Pilloni
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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