Morning Bright Light to Improve Sleep Quality in Veterans
Primary Purpose
Brain Injuries, Traumatic, Post-traumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Morning Bright Light Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries, Traumatic focused on measuring Sleep, Bright Light
Eligibility Criteria
Inclusion Criteria:
- Veterans
Exclusion Criteria:
- History of bipolar disorder
- History of macular degeneration
- Non-English speaking
- Decisionally impaired
- Currently using a light box
Sites / Locations
- VA Portland Health Care SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Morning Bright Light Therapy
Control
Arm Description
Subjects who engage in morning bight light therapy
Subjects who do not engage in morning bright light therapy
Outcomes
Primary Outcome Measures
Change in Insomnia Severity Index (ISI)
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Secondary Outcome Measures
Full Information
NCT ID
NCT03578003
First Posted
June 13, 2018
Last Updated
April 4, 2022
Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT03578003
Brief Title
Morning Bright Light to Improve Sleep Quality in Veterans
Official Title
Morning Bright Light to Improve Sleep Quality in Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
August 2, 2024 (Anticipated)
Study Completion Date
August 2, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic, Post-traumatic Stress Disorder
Keywords
Sleep, Bright Light
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morning Bright Light Therapy
Arm Type
Experimental
Arm Description
Subjects who engage in morning bight light therapy
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects who do not engage in morning bright light therapy
Intervention Type
Other
Intervention Name(s)
Morning Bright Light Therapy
Intervention Description
60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking
Primary Outcome Measure Information:
Title
Change in Insomnia Severity Index (ISI)
Description
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Time Frame
Baseline; after 4 weeks of intervention; and 2 months after the end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Veterans
Exclusion Criteria:
History of bipolar disorder
History of macular degeneration
Non-English speaking
Decisionally impaired
Currently using a light box
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miranda M Lim, MD, PhD
Phone
503-220-8262
Ext
57404
Email
lmir@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan E Elliott, PhD
Phone
503-220-8262
Ext
58020
Email
elliojon@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miranda M Lim, MD, PhD
Organizational Affiliation
Portland VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda M Lim, MD, PhD
Phone
503-220-8262
Ext
57404
Email
lmir@ohsu.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35421086
Citation
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.
Results Reference
derived
Learn more about this trial
Morning Bright Light to Improve Sleep Quality in Veterans
We'll reach out to this number within 24 hrs