Status:
COMPLETED
Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.
Lead Sponsor:
University of California, San Diego
Conditions:
Altitude Hypoxia
Ventilation
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
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 s...
Eligibility Criteria
Inclusion
- \-
Exclusion
- Sleep disorders
- Pregnant females
- Smokers (quit ≥ 1 year ago acceptable)
- Any known cardiac (apart from treated hypertension with acceptable drugs, see below), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, hepatic disease, or patients with diabetes.
- Prior or current use of melatonin.
- Use of any medications that may affect sleep or breathing, blood-thinning medications (anticoagulants), antioxidants, anti-inflammatories, medications that suppress the immune system (immunosuppressants), diabetes medications and birth control pills.
- A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- Substantial alcohol (\>3oz/day) or use of illicit drugs.
- Previous occurrence of high altitude pulmonary or cerebral edema.
- Recent exposure to altitude (\>8000ft) in the last month or having slept at an altitude \>6000ft in the last month.
- Inability to provide written informed consent or able to complete the experiment.
- Non-English speakers (necessary to complete neurocognitive testing).
- More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
Key Trial Info
Start Date :
July 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03368352
Start Date
July 4 2017
End Date
December 20 2018
Last Update
January 31 2019
Active Locations (1)
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1
UCSD Sleep Lab
San Diego, California, United States, 92103