Home-based wearable 60Hz intermittent light for major depressive episode

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

This pilot tests whether using a wearable 60Hz intermittent light headset for 30 minutes a day can help adults with a major depressive episode reduce depressive symptoms compared with a sham device.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 24 Years to 65 Years
• Sex: All
• Sponsor: NYU Langone Health (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07111390 on ClinicalTrials.gov

What this trial studies

This randomized, pilot interventional study randomizes participants 2:1 to receive either active or sham 60Hz intermittent light delivered via a wearable headset for 30 minutes daily, Monday through Friday, over three weeks. The trial is conducted remotely with clinical assessments at baseline, mid-point, post-treatment, and follow-up to measure changes in depressive symptoms and evaluate tolerability and usability. Eligible adults (24–65) must have a confirmed major depressive episode and a minimum score on the HDRS-17, and must be on a stable antidepressant regimen if applicable. The primary focus is feasibility and safety with collection of preliminary efficacy signals to inform larger trials.

Who should consider this trial

Good fit: Adults aged 24 to 65 with a confirmed diagnosis of major depressive disorder by MINI, an HDRS-17 score of 17 or higher, stable antidepressant dosing for at least 30 days, no premorbid cognitive impairment (WRAT-5 reading recognition standard score >85), English proficiency, access to a quiet home space, and a local provider for safety oversight are ideal candidates.

Not a fit: Patients with primary neurological or autoimmune disorders, significant psychiatric comorbidities, marked cognitive impairment, those outside the 24–65 age range, or those without access to a local provider, a suitable home environment, or English-language materials are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer a convenient, non-pharmacologic, at-home treatment option that may reduce depressive symptoms for some patients.

How similar studies have performed: While some forms of light therapy have shown benefit for seasonal and certain nonseasonal depressive symptoms, the specific 60Hz intermittent wearable approach is novel and lacks large-scale efficacy data to date.

Eligibility criteria

Inclusion Criteria:

* 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 at screening.
* On a stable dose of antidepressant medication for at least 30 days prior to HDRS-17 screening.
* No evidence of premorbid cognitive impairment, as demonstrated by a standard score \>85 on the WRAT-5 Reading Recognition Subtest.
* Confirmed access to a local provider that has primary responsibility for the subjects' clinical care, and who is available for contact in case of increased subject risk due to depressive symptoms.
* Able to provide informed consent and comply with study procedures.
* Access to a quiet space suitable for home-based light stimulation sessions.
* English speaking: All study materials and assessments are only validated in English

Exclusion Criteria:

* Presence of primary neurological or autoimmune disorders.
* Presence of psychiatric comorbidities as determined by the MINI interview (e.g., anxiety disorders, OCD, PTSD, bipolar disorder, psychotic disorder).
* Current or recent diagnosis of alcohol or substance use disorder.
* History of bipolar disorder or any psychotic disorder.
* Clinically significant suicidal ideation or behavior, based on clinician judgment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
* History of seizure disorder or epilepsy.
* History of migraine, tinnitus, or photosensitivity.
* Diagnosis of retinal disease, cataract, or other visual impairments that may interfere with light exposure.
* Regular use of anti-inflammatory drugs or anticoagulants (e.g., clopidogrel).
* Pregnancy and Breastfeeding: Currently pregnant, planning pregnancy during the study period, or breastfeeding

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Giuseppina Pilloni, PhD — NYU Langone Health
• Study coordinator: Shayna Pehel

Conditions: Depression, MDD, Major Depressive Disorder, Major Depressive Episode, Brain stimulation, Light therapy, Wearable, Neuromodulation