Recruiting

Bright Light Therapy

Sponsor:

Oregon Health and Science University

Code:

NCT07601841

Conditions

Sleep

Phototherapy

Glymphatic System

Mitochondrial Dynamics

Brain Injuries, Traumatic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Morning Bright Light Therapy

Negative Ion Generator Therapy

Study Details

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

Study ID

NCT07601841

Start date

Dec 12, 2025

Status verified date

May, 2026

Completion date

Sep 30, 2030

Anticipated

Primary completion date

Dec 12, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Morning Bright Light Therapy

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

other: Negative Ion Generator Therapy

Exposure to negative ions in the morning every day for an hour for 4 weeks.

Interventions

Morning Bright Light Therapy

Exposure to bright light shortly after waking.

Negative Ion Generator Therapy

Exposure to negative ions shortly after waking.

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). ]
  • 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). ]
  • 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). ]

Central Contacts and Locations

Central contacts

Jonathan Elliott, PhD

503-220-8262elliojon@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jonathan Elliott, PhD

503-220-8262elliojon@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2026-05-22.