Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.

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Brief Title

Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.

Official Title

Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.

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. 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.

Study Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Neurocognitive function

Condition

Altitude Hypoxia

Intervention

Melatonin

Study Arms / Comparison Groups

 Normoxia
Description:  Sleep in normal room air with no drug

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Dietary Supplement

Estimated Enrollment

20

Start Date

July 4, 2017

Completion Date

December 20, 2018

Primary Completion Date

December 20, 2018

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03368352

Organization ID

170200

Responsible Party

Principal Investigator

Study Sponsor

University of California, San Diego

Study Sponsor

, ,

Verification Date

January 2019