Pilot Study of Wearable 60Hz Intermittent Light Therapy at Home for Adults with Major Depressive Disorder

What this Trial Is About

Researchers are evaluating the feasibility, safety, and early effects of home-based 60Hz intermittent light therapy delivered through a wearable headset for adults experiencing a major depressive episode. This pilot study focuses on adults aged 24 to 65 with confirmed Major Depressive Disorder MDD who are on stable antidepressant medication. The study aims to understand whether this innovative light therapy can be tolerated and used effectively, with all procedures conducted remotely. Participants will be randomly assigned in a 21 ratio to receive either active 60Hz intermittent light therapy or sham light therapy, both delivered at home for 30 minutes daily from Monday through Friday over three weeks, totaling 15 sessions. The active therapy uses flickering white light at 60Hz, while the sham group receives constant white light, both via a wearable headset. During the study, participants will complete remote clinical assessments at baseline, midpoint, after treatment, and at follow-up to track changes in depressive symptoms. Researchers will monitor session completion rates, adverse effects, and use questionnaires to evaluate depression severity, anxiety levels, functionality, usability of the device, and participant experience. The study lasts for three weeks of treatment with ongoing safety and symptom monitoring throughout this period.

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