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NCT Number: NCT07601841

Light Therapy to Improve Sleep in 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.

Recruiting

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Jonathan Elliott, PhD

CONTACT

[email protected]

503-220-8262 ext. x51986

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Morning Bright Light Therapy

Device

Exposure to bright light shortly after waking.

Other names: MBLT

Negative Ion Generator Therapy

Device

Exposure to negative ions shortly after waking.

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan Elliott, PhD

CONTACT

[email protected]

503-220-8262 ext. x51986

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Acronym: GLIMPSE-LION

Important dates

Study start
2025
Primary completion
2028
Study completion
2030
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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