SleepGLIMPSE-LIONNCT07601841
Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function
A study testing Morning Bright Light Therapy and Negative Ion Generator Therapy in people with Sleep and Phototherapy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is a clinical trial designed to examine how improved sleep through morning bright light therapy is improving downstream key physiologic processes related to brain health, i.e., mitochondrial function, systemic inflammation, and glymphatic function. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Sleep, Phototherapy, Glymphatic System
- What is being tested?
- Morning Bright Light Therapy and Negative Ion Generator Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 30 Sep 2030
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
All subjects must:
- Male and female; any race; 18-89 years of age.
- Be English speaking.*
- Be accessible via phone.
- Be non-decisionally impaired. Determined by assessing the subject's ability to verbalize their understanding of the protocol back to us during the informed consent process.
- Not have a history of macular degeneration.
- Not have a history of bipolar disorder.
- Not be currently using a lightbox or a negative ion generator.
- Not be a shift worker.
- Have a documented history of TBI via the Head Trauma Events Characteristics (HTEC) or OHIO conducted in accordance with VA/DoD Clinical Practice Guidelines.88
- Present with self-reported sleep-wake disturbances.
- Remain clinically stable for current pharmacologic treatment related to depression/anxiety, sleep, and pain.
- MRI specific compatibility requirements:
- No pacemaker, wires, defribrillator or implanted heart valves
- No history of head surgery requiring aneurysm clips
- No history of other orthopedic or general surgery requiring the implantation of ferrous pins, joints, electric devices/pumps, or other foreign metal objects
- History of eye exposure to metal (unprotected welding/metalworking/shrapnel) is allowable provided the participant screens negative for metal in the eyes on an orbital x-ray or is able to provide clinical documentation of having screened negative.
- No history of non-removable hearing aids, middle/inner ear prosthesis, or dentures
- No history of claustrophobia; if unsure participant will be pre-screened in our mock scanner
- Not currently pregnant, breastfeeding, or have an implanted IUD. Participants who are unsure of their pregnancy status will be administered an hCG urine pregnancy test the day of their scan.
- Able to lay flat on their back comfortably without a thick pillow for an extended period of time.
- Shoulder width does not exceed width for safety fitting in the MRI bore.
- This study is limited to English-speaking participants because all assessments, interventions, and consent materials are currently validated and approved only in English. Expanding to other languages would require translation and psychometric validation, which are beyond the scope and budget of this study. This limitation is acknowledged and will be addressed in future research as resources permit. Finally, the study team is only fluent in English, making it infeasible to accurately consent or interact with non-English speakers without interpreting services which again is outside of the scope of this projects budget and timeline. Proceeding without formal translation services would risk miscommunication in informed consent, data collection, or participant support and thus protects participants informed consent and participant understanding.
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
Oregon Health and Science University
Portland, Oregon, 97239
Jonathan Elliott, PhD, 503-220-8262 ext. x51986, elliojon@ohsu.edu
About this study
Official title: Light Therapy to Improve Sleep in Veterans With TBI: Sleep-active Biomarkers and Glymphatic Function
This is a clinical trial designed to examine how improved sleep through morning bright light therapy is improving downstream key physiologic processes related to brain health, i.e., mitochondrial function, systemic inflammation, and glymphatic function. All proposed methodology is already approved in other IRB applications.
- Conditions
- Sleep, Phototherapy, Glymphatic System, Mitochondrial Dynamics, Brain Injuries, Traumatic, Inflammation
- Being tested
- Morning Bright Light Therapy, Negative Ion Generator Therapy
- Medical subject headings
- Brain Injuries, Traumatic, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning Bright Light TherapyDevice
Also called MBLT
Exposure to bright light shortly after waking.
Negative Ion Generator TherapyDevice
Exposure to negative ions shortly after waking.
| Study group | Role | What they receive |
|---|---|---|
| Morning Bright Light Therapy | Experimental | Exposure to bright light in the morning every day for an hour for 4 weeks. Receives: Device: Morning Bright Light Therapy |
| Negative Ion Generator Therapy | Other | Exposure to negative ions in the morning every day for an hour for 4 weeks. Receives: Device: Negative Ion Generator Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define the profile of blood-based markers of systemic inflammation pre- vs post-MBLT.
The primary outcome defines the pre- to post-intervention change in inflammatory target expression using NULISA proteomics (reporting proteins as NPQ relative units).
Measured: From pre-intervention to end of device use (Approximately 4 weeks).
Define mitochondrial function (oxygen consumption rate via Seahorse) pre- vs. post-MBLT.
The primary outcome of this aim reflects pre- to post-intervention change in mitochondrial bioenergetics. Specific metrics include basal oxygen consumption rate, maximal oxygen consumption rate, and spare/reserve capacity (difference between maximal and basal oxygen consumption rate).
Measured: From pre-intervention to end of device use (Approximately 4 weeks).
Explore glymphatic function via novel multi-model non-contrast-based MRI pre- vs. post-MBLT.
The primary outcome defines pre- to post-intervention change in MRI visibler perivascular space burden (PVS number/volume).
Measured: From pre-intervention to end of device use (Approximately 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start12 Dec 2025
- Primary completion12 Dec 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Elliott, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601841
- Sponsor's protocol ID
- STUDY00028579
- Other IDs
- TP240626
- Acronym
- GLIMPSE-LION
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Therapy to Improve Sleep in Veterans With TBI: Sleep-active Biomarkers and Glymphatic Function
- ClinicalTrials.gov ID
- NCT07601841
- Acronym / sponsor ID
- GLIMPSE-LION / STUDY00028579
- Conditions
- Sleep, Phototherapy, Glymphatic System, Mitochondrial Dynamics, Brain Injuries, Traumatic, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 12 Dec 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 22 May 2026 (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.
This is a clinical trial designed to examine how improved sleep through morning bright light therapy is improving downstream key physiologic processes related to brain health, i.e., mitochondrial function, systemic inflammation, and glymphatic function. All proposed methodology is already approved in other IRB applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Bright Light Therapy | Experimental | Device: Morning Bright Light TherapyExposure to bright light in the morning every day for an hour for 4 weeks. |
| Negative Ion Generator Therapy | Other | Device: Negative Ion Generator TherapyExposure to negative ions in the morning every day for an hour for 4 weeks. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 TherapyAlso: MBLTExposure to bright light shortly after waking. | Device | Morning Bright Light Therapy |
| Negative Ion Generator TherapyExposure to negative ions shortly after waking. | Device | Negative Ion Generator Therapy |
Primary outcome
Define the profile of blood-based markers of systemic inflammation pre- vs post-MBLT.
Time frame: From pre-intervention to end of device use (Approximately 4 weeks).
The primary outcome defines the pre- to post-intervention change in inflammatory target expression using NULISA proteomics (reporting proteins as NPQ relative units).
Define mitochondrial function (oxygen consumption rate via Seahorse) pre- vs. post-MBLT.
Time frame: From pre-intervention to end of device use (Approximately 4 weeks).
The primary outcome of this aim reflects pre- to post-intervention change in mitochondrial bioenergetics. Specific metrics include basal oxygen consumption rate, maximal oxygen consumption rate, and spare/reserve capacity (difference between maximal and basal oxygen consumption rate).
Explore glymphatic function via novel multi-model non-contrast-based MRI pre- vs. post-MBLT.
Time frame: From pre-intervention to end of device use (Approximately 4 weeks).
The primary outcome defines pre- to post-intervention change in MRI visibler perivascular space burden (PVS number/volume).
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 22 May 2026.
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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.
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 and Negative Ion Generator Therapy in people with Sleep and Phototherapy, run by Oregon Health and Science University 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?
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 22 May 2026. 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 Jonathan Elliott, PhD (503-220-8262 ext. x51986, elliojon@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define the profile of blood-based markers of systemic inflammation pre- vs post-MBLT. (time frame: From pre-intervention to end of device use (Approximately 4 weeks).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.