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NCT03578003 Clinical Trial

Morning Bright Light to Improve Sleep Quality in Veterans

Post-traumatic Stress Disorder Clinical Trial

Official title:
Morning Bright Light to Improve Sleep Quality in Veterans

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03578003
Other study ID # 4085
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2, 2017
Est. completion date August 2, 2026

Study information
Verified date April 2022
Source Portland VA Medical Center
Contact Miranda M Lim, MD, PhD
Phone 503-220-8262
Email lmir@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date August 2, 2026
Est. primary completion date August 2, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Veterans Exclusion Criteria: - History of bipolar disorder - History of macular degeneration - Non-English speaking - Decisionally impaired - Currently using a light box

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Morning Bright Light Therapy
60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking

Locations
Country Name City State
United States VA Portland Health Care System Portland Oregon

Sponsors (2)
Lead Sponsor Collaborator
Portland VA Medical Center Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Insomnia Severity Index (ISI) Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia) Baseline; after 4 weeks of intervention; and 2 months after the end of intervention
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