Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude
1 other identifier
interventional
39
1 country
1
Brief 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.Therefore this study aims to determine how melatonin effects control of breathing, sleep and mental performance during exposure to low oxygen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 3, 2018
CompletedStudy Start
First participant enrolled
January 10, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedAugust 14, 2019
August 1, 2019
11 months
January 3, 2018
August 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Apnea Hypopnea Index
Measure of Sleep Apnea severity
6 weeks
Neurocognitive Scores
Reflex changes between conditions
6 weeks
Secondary Outcomes (6)
Loop Gain
6 weeks
Arousal Threshold
6 weeks
Sleep Efficiency
6 weeks
Total Antioxidant Status
6 weeks
Hypoxic Ventilatory Response
6 weeks
- +1 more secondary outcomes
Study Arms (3)
Normoxia
NO INTERVENTIONParticipants will sleep in room air and receive no melatonin.
Hypoxia and Placebo
PLACEBO COMPARATOR5mg placebo before sleep study
Hypoxia and Melatonin
EXPERIMENTAL5mg melatonin before sleep study
Interventions
Eligibility Criteria
You may qualify if:
- Healthy Males and Females
- Age:18-65 years
You may not qualify if:
- Sleep Disorders
- Pregnant Females
- Smokers (quit ≥ 1 year ago acceptable)
- Cardiovascular, Pulmonary, Renal, Neurologic, Neuromuscular, or Hepatic Issues
- Diabetes
- Psychiatric disorder, other than mild depression
- Recent exposure to altitude (\>8000ft) in the last month or having slept at an altitude \>6000ft in the last month
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Robert L. Owenslead
Study Sites (1)
University of California, San Diego
San Diego, California, 92093, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Atul Malhotra, MD
Professor
- STUDY DIRECTOR
Naomi L Deacon, Ph.D.
Research Associate
- STUDY CHAIR
Pamela De Young
Research Associate
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Physician
Study Record Dates
First Submitted
January 3, 2018
First Posted
July 17, 2018
Study Start
January 10, 2018
Primary Completion
December 10, 2018
Study Completion
December 10, 2018
Last Updated
August 14, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share