CClinicalTrials.gg
CompletedNCT03588676Updated Aug 14, 2019

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

An interventional study of Melatonin and Placebo in Intermittent Hypoxia, sponsored by Robert L. Owens. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-14.

Sponsored by Robert L. Owens · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
39
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Research has shown that exposure to low oxygen at altitude causes neurocognitive impairment (impaired mental processing, memory, attention, learning, etc). This impairment in cognitive performance poses a serious risk to mountain climbers and while it has traditionally been thought that people who live at high altitude have adapted to it, evidence shows there is still considerable damage to the brain and impairments in cognitive function of people who live and work at high altitude.

As every cell in the body requires oxygen to survive and function, impairment in cognitive performance at altitude is thought mainly due to reduced oxygen availability to the central nervous system. However, low oxygen at altitude also causes unstable breathing during sleep which results in short periods where the brain stops sending the signal to breath, called central sleep apnea (CSA). During apneas (pauses in breathing) blood oxygen drops even lower and people typically wake up briefly and hyperventilate after apneas. Therefore at altitude people usually get less sleep, their sleep is broken with periods of wakefulness during the night and they experience repeated bouts of severe low blood oxygen levels. Sleep plays a critical role in how the brain repairs and also converts newly acquired information into long-term memory. Therefore broken and reduced sleep can impair cognitive performance, memory and learning. Repeated bouts of severe low oxygen also produces highly reactive molecules that cause damage to cells, called oxidative stress. Oxidative stress also prevents the brain from forming long-term memories and in severe cases (such as extremely high altitude and long duration exposure) can cause neurons in the brain to die. Therefore although sustained low oxygen at altitude likely impairs cognitive function, disturbed sleep and repeated bouts of severely low oxygen likely also contribute to causing brain damage and impaired cognitive performance.

Melatonin is a hormone produced in the pineal gland of the brain during the night which signals to the brain that it is time to sleep. Melatonin is also a very powerful antioxidant which naturally helps to prevent damage in the body from oxidative stress. A study previously reported that melatonin taken 90 mins before bed at 4,300 m (14,200 ft) reduced the time taken to fall asleep, it reduced the number of times people woke up during sleep and improved cognitive performance the following day. However how melatonin caused these effects was not determined. Therefore this study aims to determine how melatonin affects ventilatory control, sleep and neurocognitive performance during sustained hypoxia.

02

Conditions studied

  • Intermittent Hypoxia

Browse trials for

Keywords

  • Hypoxia
  • High Altitude
  • Melatonin
  • Neurocognitive
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 39 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

Browse Hypoxia studies →

Lead sponsor

This is the only study on the registry with Robert L. Owens as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Males and Females
  • Age:18-65 years

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
39 participants (actual)

Study arms

  • No intervention
    Normoxia

    Participants will sleep in room air and receive no melatonin.

  • Placebo comparator
    Hypoxia and Placebo

    5mg placebo before sleep study

    Other: Placebo

  • Experimental
    Hypoxia and Melatonin

    5mg melatonin before sleep study

    Other: Melatonin

Interventions

  • OtherMelatonin

    5mg Melatonin

  • OtherPlacebo

    5mg Placebo capsule

06

What researchers measure

Primary outcomes

  1. Change in Apnea Hypopnea Index

    Measure of Sleep Apnea severity

    Time frame: 6 weeks

  2. Neurocognitive Scores

    Reflex changes between conditions

    Time frame: 6 weeks

Secondary outcomes

  1. Loop Gain

    Measurement of breathing characteristics during sleep using a flow meter attached to a CPAP mask that allows the measurement of expiratory flow

    Time frame: 6 weeks

  2. Arousal Threshold

    requirements for sleep arousal to occur

    Time frame: 6 weeks

  3. Sleep Efficiency

    Time in bed divided by total sleep time

    Time frame: 6 weeks

  4. Total Antioxidant Status

    Measurement taken from blood draw

    Time frame: 6 weeks

  5. Hypoxic Ventilatory Response

    Change in breathing response while breathing low oxygen

    Time frame: 6 weeks

  6. Hypercapnic Ventilatory Response

    Change in breathing response while breathing high carbon dioxide

    Time frame: 6 weeks

07

Study locations

1 site
  • University of California, San Diego
    San Diego, California 92093, United States
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03588676
Lead sponsor
Robert L. Owens
Responsible party
Robert L. Owens (Associate Physician, University of California, San Diego) — Sponsor-investigator
First posted
Jul 17, 2018
Start date
Jan 10, 2018
Primary completion
Dec 10, 2018
Completion
Dec 10, 2018
Last update
Aug 14, 2019

Study contacts

Atul Malhotra, MD
principal investigator · Professor
Naomi L Deacon, Ph.D.
study director · Research Associate
Pamela De Young
study chair · Research Associate

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion