- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07601841
Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function (GLIMPSE-LION)
18. mai 2026 oppdatert av: Jonathan Elliott, Oregon Health and Science University
Light Therapy to Improve Sleep in Veterans With TBI: Sleep-active Biomarkers and Glymphatic Function
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
300
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jonathan Elliott, PhD
- Telefonnummer: x51986 503-220-8262
- E-post: elliojon@ohsu.edu
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forente stater, 97239
- Rekruttering
- Oregon Health and Science University
-
Ta kontakt med:
- Jonathan Elliott, PhD
- Telefonnummer: x51986 503-220-8262
- E-post: elliojon@ohsu.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
- 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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Morning Bright Light Therapy
Exposure to bright light in the morning every day for an hour for 4 weeks.
|
Exposure to bright light shortly after waking.
Andre navn:
|
|
Annen: Negative Ion Generator Therapy
Exposure to negative ions in the morning every day for an hour for 4 weeks.
|
Exposure to negative ions shortly after waking.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Define the profile of blood-based markers of systemic inflammation pre- vs post-MBLT.
Tidsramme: From pre-intervention to end of device use (Approximately 4 weeks).
|
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.
Tidsramme: From pre-intervention to end of device use (Approximately 4 weeks).
|
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.
Tidsramme: From pre-intervention to end of device use (Approximately 4 weeks).
|
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).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
12. desember 2025
Primær fullføring (Antatt)
12. desember 2028
Studiet fullført (Antatt)
30. september 2030
Datoer for studieregistrering
Først innsendt
28. april 2026
Først innsendt som oppfylte QC-kriteriene
18. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY00028579
- TP240626 (Annet stipend/finansieringsnummer: Defense Health Advisory)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .