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OpenTrials
Completed

NCT Number: NCT03368352

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 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.

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Key information

Conditions

Altitude Hypoxia Altitude Sickness Cognition Disorders Mental Disorders Neurocognitive Disorders Neurocognitive Dysfunction Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Sleep Ventilation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

UCSD Sleep Lab

San Diego, California, 92103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

Exclusion criteria

  • 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.

Treatment and study plan

melatonin

Dietary Supplement

Dietary supplement melatonin

Hypoxia

Other

Sleep in a hypoxic tent simulating high altitude

Primary outcomes

  1. Neurocognitive function

    Time frame: 30 minutes after arousal from sleep

    Stroop-color word test median number of errors. Higher numbers indicate worse performance.

  2. Endothelial function

    Time frame: 5 minutes after arousal from sleep

    Reactive hypermedia index via EndoPat

  3. Lipid peroxidation in serum

    Time frame: immediately after arousal from sleep

    Concentration of Malondialdehyde in serum samples

  4. Hypercapnic hypoxic ventilatory sensitivity

    Time frame: 1 hour after arousal from sleep

    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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2017
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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