Morning Bright Light to Improve Sleep Quality in Veterans

April 4, 2022 updated by: Miranda M Lim, Portland VA Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jonathan E Elliott, PhD
  • Phone Number: 58020 503-220-8262
  • Email: elliojon@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • VA Portland Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veterans

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Morning Bright Light Therapy
Subjects who engage in morning bight light therapy
Other: Morning Bright Light Therapy
60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking
NO_INTERVENTION: Control
Subjects who do not engage in morning bright light therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline; after 4 weeks of intervention; and 2 months after the end of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portland VA Medical Center

Collaborators

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 2, 2017

Primary Completion (ANTICIPATED)

August 2, 2024

Study Completion (ANTICIPATED)

August 2, 2026

Study Registration Dates

First Submitted

June 13, 2018

First Submitted That Met QC Criteria

June 22, 2018

First Posted (ACTUAL)

July 5, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All non-identifiable data will be made available to qualified researchers on request to the study PI.

IPD Sharing Time Frame

Information will be sent as soon as is practical and will be available as long as the PI is available.

IPD Sharing Access Criteria

Legitimate research agenda, including but not limited to request to double-check presented or published results and novel analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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