Morning Bright Light to Improve Sleep Quality in Veterans

NCT03578003 | Recruiting DMC

• 1 other identifier: 4085
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic; Post-traumatic Stress Disorder

Keywords

Sleep; Bright Light

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Morning Bright Light Therapy

EXPERIMENTAL

Subjects who engage in morning bight light therapy

Other: Morning Bright Light Therapy

Control

NO INTERVENTION

Subjects who do not engage in morning bright light therapy

Interventions

Morning Bright Light Therapy OTHER

60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking

Morning Bright Light Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans

You may not qualify if:

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

Sponsors & Collaborators

• Portland VA Medical Center: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System

Portand, Oregon, 97239, United States

RECRUITING

Related Publications (1)

• Elliott JE, McBride AA, Balba NM, Thomas SV, Pattinson CL, Morasco BJ, Wilkerson A, Gill JM, Lim MM. Feasibility and preliminary efficacy for morning bright light therapy to improve sleep and plasma biomarkers in US Veterans with TBI. A prospective, open-label, single-arm trial. PLoS One. 2022 Apr 14;17(4):e0262955. doi: 10.1371/journal.pone.0262955. eCollection 2022.

  PMID: 35421086 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Miranda M Lim, MD, PhD

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miranda M Lim, MD, PhD

CONTACT

503-220-8262; lmir@ohsu.edu

Jonathan E Elliott, PhD

CONTACT

503-220-8262; elliojon@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician and Assistant Professor

Study Record Dates

• First Submitted: June 13, 2018
• First Posted: July 5, 2018
• Study Start: August 2, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Information will be sent as soon as is practical and will be available as long as the PI is available.
• Access Criteria: Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.

Locations

US (1)