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Trial record 8 of 32 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Oregon, United States ) | NIH, U.S. Fed

Morning Bright Light to Improve Sleep Quality in Veterans

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ClinicalTrials.gov Identifier: NCT03578003
Recruitment Status : Recruiting
First Posted : July 4, 2018
Last Update Posted : January 23, 2019
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Miranda M Lim, Portland VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Post-traumatic Stress Disorder Other: Morning Bright Light Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Morning Bright Light to Improve Sleep Quality in Veterans
Actual Study Start Date : August 2, 2017
Estimated Primary Completion Date : August 2, 2020
Estimated Study Completion Date : August 2, 2021

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



Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veterans

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578003


Contacts
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Contact: Miranda M Lim, MD, PhD 503-220-8262 ext 57404 lmir@ohsu.edu
Contact: Jonathan E Elliott, PhD 503-220-8262 ext 58020 elliojon@ohsu.edu

Locations
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United States, Oregon
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97239
Contact: Miranda M Lim, MD, PhD    503-220-8262 ext 57404    lmir@ohsu.edu   
Sponsors and Collaborators
Portland VA Medical Center
Oregon Health and Science University
Investigators
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Principal Investigator: Miranda M Lim, MD, PhD Portland VA Medical Center

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Responsible Party: Miranda M Lim, Staff Physician and Assistant Professor, Portland VA Medical Center
ClinicalTrials.gov Identifier: NCT03578003     History of Changes
Other Study ID Numbers: 4085
First Posted: July 4, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All non-identifiable data will be made available to qualified researchers on request to the study PI.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

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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

Keywords provided by Miranda M Lim, Portland VA Medical Center:
Sleep
Bright Light

Additional relevant MeSH terms:
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Brain Injuries
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Trauma and Stressor Related Disorders
Mental Disorders