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.
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
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.
- Conditions
- Intermittent 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 group | Role | What they receive |
|---|---|---|
| Normoxia | No intervention | Participants will sleep in room air and receive no melatonin. |
| Hypoxia and Placebo | Placebo comparator | 5mg placebo before sleep study Receives: Other: Placebo |
| Hypoxia and Melatonin | Experimental | 5mg melatonin before sleep study Receives: Other: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea Hypopnea Index
Measure of Sleep Apnea severity
Measured: 6 weeks
Neurocognitive Scores
Reflex changes between conditions
Measured: 6 weeks
Secondary outcomes (6)
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
Arousal Threshold
requirements for sleep arousal to occur
Measured: 6 weeks
Sleep Efficiency
Time in bed divided by total sleep time
Measured: 6 weeks
Total Antioxidant Status
Measurement taken from blood draw
Measured: 6 weeks
Hypoxic Ventilatory Response
Change in breathing response while breathing low oxygen
Measured: 6 weeks
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.
- First posted17 Jul 2018
- Study start10 Jan 2018
- Primary completion10 Dec 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Robert L. Owens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Atul Malhotra, MD, Principal investigator, ProfessorNaomi L Deacon, Ph.D., Study director, Research AssociatePamela De Young, Study chair, Research Associate
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude
- ClinicalTrials.gov ID
- NCT03588676
- Acronym / sponsor ID
- UCSD170200
- Conditions
- Intermittent Hypoxia
- Keywords
- Hypoxia, High Altitude, Melatonin, Neurocognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Robert L. OwensUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, placebo controlled, double blind, cross-over trial
| Arm | Type | Receives |
|---|---|---|
| Normoxia | No intervention | –Participants will sleep in room air and receive no melatonin. |
| Hypoxia and Placebo | Placebo comparator | Other: Placebo5mg placebo before sleep study |
| Hypoxia and Melatonin | Experimental | Other: Melatonin5mg melatonin before sleep study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Males and Females
- Age:18-65 years
Key exclusion criteria (7 listed)
- Sleep Disorders
- Pregnant Females
- Smokers (quit ≥ 1 year ago acceptable)
- Cardiovascular, Pulmonary, Renal, Neurologic, Neuromuscular, or Hepatic Issues
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin5mg Melatonin | Other | Hypoxia and Melatonin |
| Placebo5mg Placebo capsule | Other | Hypoxia and Placebo |
Primary outcome
Change in Apnea Hypopnea Index
Time frame: 6 weeks
Measure of Sleep Apnea severity
Neurocognitive Scores
Time frame: 6 weeks
Reflex changes between conditions
6 secondary outcomes
Loop Gain
Time frame: 6 weeks
Arousal Threshold
Time frame: 6 weeks
Sleep Efficiency
Time frame: 6 weeks
Total Antioxidant Status
Time frame: 6 weeks
Hypoxic Ventilatory Response
Time frame: 6 weeks
Hypercapnic Ventilatory Response
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Intermittent Hypoxia
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Influence of Intermittent Hypoxia on Loop Gain in Healthy Subjects
Intermittent Hypoxia, Healthy Volunteers
Not yet recruiting
Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis
Internal Carotid Artery Stenosis
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Brain Connectivity and Corticospinal Excitability in Response to Moderate Hypoxia
Normoxia, Intermittent Moderate Hypoxia
Recruiting
BioFLO for Respiratory Recovery in SCI
Spinal Cord Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul Malhotra, MD principal investigator
Professor
Naomi L Deacon, Ph.D. study director
Research Associate
Pamela De Young study chair
Research Associate
1 site in 1 country: see every site and its status.
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.