Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function

NCT07601841 | Recruiting

• 2 other identifiers: STUDY00028579TP240626
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. All proposed methodology is already approved in other IRB applications.

Conditions

Sleep; Phototherapy; Glymphatic System; Mitochondrial Dynamics; Brain Injuries, Traumatic; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  From pre-intervention to end of device use (Approximately 4 weeks).

Study Arms (2)

Morning Bright Light Therapy

EXPERIMENTAL

Exposure to bright light in the morning every day for an hour for 4 weeks.

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.

Device: Negative Ion Generator Therapy

Interventions

Morning Bright Light Therapy DEVICE

Exposure to bright light shortly after waking.

Also known as: MBLT

Morning Bright Light Therapy

Negative Ion Generator Therapy DEVICE

Exposure to negative ions shortly after waking.

Negative Ion Generator Therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

All subjects must: 1. Male and female; any race; 18-89 years of age. 2. Be English speaking.\* 3. Be accessible via phone. 4. 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. 5. Not have a history of macular degeneration. 6. Not have a history of bipolar disorder. 7. Not be currently using a lightbox or a negative ion generator. 8. Not be a shift worker. 9. 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 10. Present with self-reported sleep-wake disturbances. 11. Remain clinically stable for current pharmacologic treatment related to depression/anxiety, sleep, and pain. 12. 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Inflammation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jonathan Elliott, PhD

CONTACT

503-220-8262; elliojon@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 22, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): December 12, 2028
• Study Completion (Estimated): September 30, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)