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Clinical Trials/NCT03578003
NCT03578003
Recruiting
Not Applicable

Morning Bright Light to Improve Sleep Quality in Veterans

Portland VA Medical Center1 site in 1 country200 target enrollmentAugust 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Injuries, Traumatic
Sponsor
Portland VA Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Change in Insomnia Severity Index (ISI)
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.

Registry
clinicaltrials.gov
Start Date
August 2, 2017
End Date
December 1, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miranda M Lim

Staff Physician and Assistant Professor

Portland VA Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • History of bipolar disorder
  • History of macular degeneration
  • Non-English speaking
  • Decisionally impaired
  • Currently using a light box

Outcomes

Primary Outcomes

Change in Insomnia Severity Index (ISI)

Time Frame: Baseline; after 4 weeks of intervention; and 2 months after the end of intervention

Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)

Study Sites (1)

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