An Early Phase 1 interventional study of Melatonin and Hypoxia in Altitude Hypoxia, Ventilation and Sleep, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by University of California, San Diego · Early Phase 1, Interventional, and Basic science
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.
Inclusion Criteria:
-
Exclusion Criteria:
Sleep in normal room air with no drug
Sleep in hypoxic tent after taking Placebo 1 hour before bed.
Other: Hypoxia
Sleep in hypoxic tent after taking 5 mg Melatonin before bed.
Dietary Supplement: Melatonin
Dietary supplement melatonin
Sleep in a hypoxic tent simulating high altitude
Neurocognitive function
Stroop-color word test median number of errors. Higher numbers indicate worse performance.
Time frame: 30 minutes after arousal from sleep
Endothelial function
Reactive hypermedia index via EndoPat
Time frame: 5 minutes after arousal from sleep
Lipid peroxidation in serum
Concentration of Malondialdehyde in serum samples
Time frame: immediately after arousal from sleep
Hypercapnic hypoxic ventilatory sensitivity
This is the one outcome. It is the gain of the ventilatory response to changes in CO2, during sustained hypoxia. Delta minute ventilation / delta mmHg CO2 during sustained hypoxia
Time frame: 1 hour after arousal from sleep
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Diego