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

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

ArmDescriptionAssigned Intervention
Experimental
Morning Bright Light Therapy
Exposure to bright light in the morning every day for an hour for 4 weeks.
  • Device: Morning Bright Light Therapy
    Exposure to bright light shortly after waking.
    Other names:
    • MBLT
Other
Negative Ion Generator Therapy
Exposure to negative ions in the morning every day for an hour for 4 weeks.
  • Device: Negative Ion Generator Therapy
    Exposure to negative ions shortly after waking.

Recruiting Locations

Oregon Health and Science University
Portland, Oregon 97239
Contact:
Jonathan Elliott, PhD
503-220-8262
elliojon@ohsu.edu

More Details

Status
Recruiting
Sponsor
Oregon Health and Science University

Study Contact

Jonathan Elliott, PhD
503-220-8262
elliojon@ohsu.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.