Brain Injuries, TraumaticNCT03578003
Morning Bright Light to Improve Sleep Quality in Veterans
A study testing Morning Bright Light Therapy in people with Brain Injuries, Traumatic and Post-traumatic Stress Disorder, run by Portland VA Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic, Post-traumatic Stress Disorder
- What is being tested?
- Morning Bright Light Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veterans
Who cannot join
- History of bipolar disorder
- History of macular degeneration
- Non-English speaking
- Decisionally impaired
- Currently using a light box
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Portland Health Care System
Portand, Oregon, 97239
Miranda M Lim, MD, PhD, 503-220-8262 ext. 57404, lmir@ohsu.edu
About this study
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.
- Being tested
- Morning Bright Light Therapy
- Keywords
- Sleep, Bright Light
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Bright Light TherapyOther
60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking
| Study group | Role | What they receive |
|---|---|---|
| Morning Bright Light Therapy | Experimental | Subjects who engage in morning bight light therapy Receives: Other: Morning Bright Light Therapy |
| Control | No intervention | Subjects who do not engage in morning bright light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI)
Measures self-reported insomnia severity; total score range = 0-28 (higher total score = worse insomnia)
Measured: Baseline; after 4 weeks of intervention; and 2 months after the end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start2 Aug 2017
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Miranda M Lim, Portland VA Medical Center
- Investigators
- Miranda M Lim, MD, PhD, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578003
- Sponsor's protocol ID
- 4085
- Status last verified
- Nov 2025
- First submitted
- 13 Jun 2018
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All non-identifiable data will be made available to qualified researchers on request to the study PI.
Publications
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.
PubMed 35421086
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morning Bright Light to Improve Sleep Quality in Veterans
- ClinicalTrials.gov ID
- NCT03578003
- Acronym / sponsor ID
- 4085
- Keywords
- Sleep, Bright Light
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Bright Light Therapy | Experimental | Other: Morning Bright Light TherapySubjects who engage in morning bight light therapy |
| Control | No intervention | –Subjects who do not engage in morning bright light therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans
Key exclusion criteria (5 listed)
- History of bipolar disorder
- History of macular degeneration
- Non-English speaking
- Decisionally impaired
- Currently using a light box
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morning Bright Light Therapy60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking | Other | Morning Bright Light Therapy |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Derived from this study: PubMed 35421086Elliott 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.
- Individual participant dataSharing planned: Yes. All non-identifiable data will be made available to qualified researchers on request to the study PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miranda M Lim, MD, PhD principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Bright Light Therapy in people with Brain Injuries, Traumatic and Post-traumatic Stress Disorder, run by Portland VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miranda M Lim, MD, PhD (503-220-8262 ext. 57404, lmir@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) (time frame: Baseline; after 4 weeks of intervention; and 2 months after the end of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03578003, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.