CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Bright White Light (BWL) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01725750
NCT01725750N/ACompleted

Treatment of Post-TBI Fatigue With Light Therapy

Icahn School of Medicine at Mount Sinai·interventional·Posted Nov 14, 2012·Updated Aug 7, 2019

In Brief

A clinical study evaluating Bright White Light (BWL) and Dim Red Light (DRL) for Traumatic Brain Injury and Fatigue. Completed, enrolled 88 participants across 1 site.

Detailed Summary

This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white light treatment will report significant reductions in fatigue compared to individuals receiving dim red light treatment for the same duration of time, and that these treatment effects will be maintained one month after treatment completion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 14, 2012
Enrollment StartNov 1, 2012
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 13.6 years ago

Interventions

Bright White Light (BWL)device

Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.

Dim Red Light (DRL)device

A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18" from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box.