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| ID | Type | Description | Link |
|---|---|---|---|
| TP240626 | Other Grant/Funding Number | Defense Health Advisory |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Morning Bright Light Therapy | Experimental | Exposure to bright light in the morning every day for an hour for 4 weeks. |
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| Negative Ion Generator Therapy | Other | Exposure to negative ions in the morning every day for an hour for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morning Bright Light Therapy | Device | Exposure to bright light shortly after waking. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Elliott, PhD | Contact | 503-220-8262 | x51986 | elliojon@ohsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health and Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| Negative Ion Generator Therapy | Device | Exposure to negative ions shortly after waking. |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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