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Intermittent HypoxiaNCT03588676

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

A study testing Melatonin in people with Intermittent Hypoxia, run by Robert L. Owens at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Intermittent Hypoxia
What is being tested?
Melatonin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
39 participants
Where
1 siteUnited States
Study dates
10 Jan 2018to 10 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, San Diego

    San Diego, California, 92093

Other trials in United States

About this study

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.

Being tested
Melatonin, Placebo
Keywords
Hypoxia, High Altitude, Melatonin, Neurocognitive
Medical subject headings
Hypoxia, Altitude Sickness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MelatoninOther

    5mg Melatonin

  • PlaceboOther

    5mg Placebo capsule

Study groups in NCT03588676
Study groupRoleWhat they receive
NormoxiaNo interventionParticipants will sleep in room air and receive no melatonin.
Hypoxia and PlaceboPlacebo comparator5mg placebo before sleep study
Receives: Other: Placebo
Hypoxia and MelatoninExperimental5mg melatonin before sleep study
Receives: Other: Melatonin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Apnea Hypopnea Index

    Measure of Sleep Apnea severity

    Measured: 6 weeks

  2. Neurocognitive Scores

    Reflex changes between conditions

    Measured: 6 weeks

Secondary outcomes (6)
  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

    Measured: 6 weeks

  2. Arousal Threshold

    requirements for sleep arousal to occur

    Measured: 6 weeks

  3. Sleep Efficiency

    Time in bed divided by total sleep time

    Measured: 6 weeks

  4. Total Antioxidant Status

    Measurement taken from blood draw

    Measured: 6 weeks

  5. Hypoxic Ventilatory Response

    Change in breathing response while breathing low oxygen

    Measured: 6 weeks

  6. Hypercapnic Ventilatory Response

    Change in breathing response while breathing high carbon dioxide

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2018
  2. Study start10 Jan 2018
  3. Primary completion10 Dec 2018
  4. Study completion10 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
randomized, placebo controlled, double blind, cross-over trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03588676
Sponsor's protocol ID
UCSD170200
Status last verified
Aug 2019
First submitted
3 Jan 2018
Last updated
14 Aug 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Melatonin in people with Intermittent Hypoxia, run by Robert L. Owens at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Apnea Hypopnea Index (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.

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