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

NCT07111390 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-26

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

60Hz Intermittent Light Therapy

Intermittent 60 Hz flickering white light delivered via a wearable headset.

DEVICE

Sham Light Therapy

Constant white light delivered via a wearable headset.

Sponsors & Collaborators

Principal Investigators

  • Giuseppina Pilloni, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2026-02-01
Completion
2026-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111390 on ClinicalTrials.gov