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NCT03368352 · ClinicalTrials.gov registry record · Early Phase 1
Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.
A Early Phase 1 study of Sleep and Oxidative Stress, sponsored by University of California, San Diego.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03368352: Completed Early Phase 1 study of Sleep and Oxidative Stress, sponsored by University of California, San Diego.
NCT03368352 is a Early Phase 1 study of Sleep and Oxidative Stress that has completed, run by University of California, San Diego. The registered enrollment target is 20 participants, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03368352, a Early Phase 1 study of Sleep and Oxidative Stress, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Low oxygen at altitude causes pauses in breathing during sleep, called central sleep apnea. Central sleep apnea causes repeated awakenings and poor sleep. Low oxygen itself and the induced oxidative stress can damage mental function which is likely worsened by poor sleep. Reduced mental function due to low oxygen can pose a serious danger to mountain climbers. However there is also mounting evidence that even in populations of people that live at high altitudes and are considered adapted, low oxygen contributes to reductions in learning and memory. Therefore there is a serious need for treatments which may improve sleep, control of breathing and mental function during low oxygen. Melatonin is a hormone produced in the brain during the night which regulates sleep patterns with strong antioxidant and anti-inflammatory properties. A study previously reported that melatonin taken 90 mins before bed at 4,300 m (14,200 ft) induced sleep earlier, reduced awakenings and improved mental performance the following day. However how melatonin caused these effects was not determined. Therefore this study aims to determine how melatonin effects control of breathing, sleep and mental performance during exposure to low oxygen.
Primary Outcome
Stroop-color word test median number of errors. Higher numbers indicate worse performance.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Melatonin
- OTHER Hypoxia
Study Locations (1)
California
- UCSD Sleep Lab - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-07-04 |
| Est. Completion | 2018-12-20 |
| Phase | Early Phase 1 |
What the finished NCT03368352 record still lists
NCT03368352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (100% lower).
The record links to 5 conditions, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which Melatonin is the first listed.
NCT03368352 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03368352 about?
NCT03368352 is a clinical study titled "Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.". Low oxygen at altitude causes pauses in breathing during sleep, called central sleep apnea. Central sleep apnea causes repeated awakenings and poor sleep. Low oxygen itself and the induced oxidative stress can damage mental function which is likely worsened by poor sleep. Reduced mental function due...
What is the current status of trial NCT03368352?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2017-07-04. Estimated completion is 2018-12-20.
What conditions does trial NCT03368352 study?
This clinical trial studies the following conditions: Sleep, Oxidative Stress, Neurocognitive Dysfunction, Ventilation, Altitude Hypoxia.
What interventions are being tested in trial NCT03368352?
The interventions under investigation include: Melatonin (DIETARY_SUPPLEMENT), Hypoxia (OTHER).
Who is sponsoring clinical trial NCT03368352?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03368352 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03368352's enrollment target sits among peer trials
20 134th of 151 higher than 12 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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