Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function
Purpose
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
Eligibility
- Eligible Ages
- Between 18 Years and 89 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Portland, Oregon 97239
More Details
- Status
- Recruiting
- Sponsor
- Oregon Health and Science University