Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorOregon Health and Science University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Morning Bright Light Therapy

    Device

    Exposure to bright light shortly after waking.

  • Negative Ion Generator Therapy

    Device

    Exposure to negative ions shortly after waking.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Morning Bright Light TherapyExperimental treatment 1 intervention
Group B: Negative Ion Generator TherapyOther 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From pre-intervention to end of device use (Approximately 4 weeks).
2

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).

Time frame
From pre-intervention to end of device use (Approximately 4 weeks).
3

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).

Time frame
From pre-intervention to end of device use (Approximately 4 weeks).

Secondary outcomes

Other outcomes

Sponsors and contacts

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