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NCT05382923
Circadian Acclimatization of Performance, Sleep, and 6-sulphatoxymelatonin Using Multiple Phase-Shifting Stimuli
NA trial testing Bright Light in Circadian Rhythm Sleep Disorder, Jet Lag Type in 36 participants. Status unknown.
1 May 2023
Quick facts
| Lead sponsor | University of Arizona |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | basic science |
| Enrollment | 36 |
| Start date | 10 July 2021 |
| Primary completion | 1 May 2023 |
| Estimated completion | 1 May 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Bright Light
- Bright Light + Exercise + Melatonin
- Control
Conditions studied
- Circadian Rhythm Sleep Disorder, Jet Lag Type — all drugs for Circadian Rhythm Sleep Disorder, Jet Lag Type →
Sponsor
University of Arizona
Who can join
Adults 18 to 45, any sex, with Circadian Rhythm Sleep Disorder, Jet Lag Type. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change (shift) in the acrophase of urinary 6-sulphatoxymelatonin (aMT6s) excretion
Time frame: 6.5 days
Change (shift) in the cosine fitted peak for the assessments (every 90 min) during lab days 2-3 compared with the assessments taken during days 6-7 -
Change (shift) in the acrophase of the rhythm of the median reaction time
Time frame: 6.5 days
Change (shift) in the cosine fitted peak for the assessments (psychomotor vigilance, every 3 h) taken during days 2-3 compared with the assessments taken during days 6-7 -
Change in sleep duration
Time frame: 5 days
Change in total sleep time assessed during night one in the lab and night 5 in the lab duration
Sponsor's own description
The aims of this study are to compare 3 different treatments for circadian adjustment to a laboratory protocol which will mimic westward air travel across 8 time zones. One treatment will involve simply following the new schedule for 3 days. Another treatment will also involve exposure to bright light for 1 hour per day. A third treatment will involve exposure to bright light + exercise for 1 hour per day + consuming a melatonin tablet. Adjustment to the shifted schedule will be assessed by comparing measures of sleep, mood, mental performance, physical performance, and timing of melatonin across the 3 treatment conditions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05382923
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Bright Light
Trials testing the same drug.
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- NCT03331822 — The Effects of Bright Light Exposure on ICU Nurses · NA · completed
- NCT03188263 — Morning Light Treatment to Improve Glucose Metabolism · NA · completed
Other University of Arizona trials
Trials by the same sponsor.
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- NCT05569486 — Elucidating the Central Mechanisms of Action for Green Light Therapy in Managing Chronic Pain · NA · not yet recruiting
- NCT05064111 — Utility of Adding MR Fusion to Standard US Guided Prostate Biopsy · suspended
- NCT06567899 — Mechanistic Underpinnings of Preeclampsia · not yet recruiting
- NCT07254793 — Prophylactic and Therapeutic DLI-X for Leukemia Relapse After HCT · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05382923 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arizona
- Last refreshed: 16 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05382923.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing