About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Morning Bright Light Therapy
DeviceExposure to bright light shortly after waking.
Negative Ion Generator Therapy
DeviceExposure to negative ions shortly after waking.
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
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).
Sponsors and contacts
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