Altitude HypoxiaEarly Phase 1NCT03368352
Effects of Melatonin on Sleep, Ventilatory Control and Cognition at Altitude.
A Early Phase 1 study testing Melatonin and Hypoxia in people with Altitude Hypoxia and Ventilation, run by University of California, San Diego 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
- Altitude Hypoxia, Ventilation, Sleep
- What is being tested?
- Melatonin and Hypoxia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jul 2017to 20 Dec 2018
- Phase
- Early Phase 1
- 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
- -
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
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. 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.
- Being tested
- Melatonin, Hypoxia
- Keywords
- Melatonin, Altitude, Sleep, Ventilation, Cognition
- Medical subject headings
- Altitude Sickness, Respiratory Aspiration, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Dietary supplement melatonin
HypoxiaOther
Sleep in a hypoxic tent simulating high altitude
| Study group | Role | What they receive |
|---|---|---|
| Normoxia | No intervention | Sleep in normal room air with no drug |
| Hypoxia with Placebo | Placebo comparator | Sleep in hypoxic tent after taking Placebo 1 hour before bed. Receives: Other: Hypoxia |
| Hypoxia with Melatonin | Experimental | Sleep in hypoxic tent after taking 5 mg Melatonin before bed. Receives: Dietary Supplement: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive function
Stroop-color word test median number of errors. Higher numbers indicate worse performance.
Measured: 30 minutes after arousal from sleep
Endothelial function
Reactive hypermedia index via EndoPat
Measured: 5 minutes after arousal from sleep
Lipid peroxidation in serum
Concentration of Malondialdehyde in serum samples
Measured: immediately after arousal from sleep
Hypercapnic hypoxic ventilatory sensitivity
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
Measured: 1 hour after arousal from sleep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start4 Jul 2017
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Altitude HypoxiaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naomi Deacon, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368352
- Sponsor's protocol ID
- 170200
- Status last verified
- Jan 2019
- First submitted
- 20 Nov 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- 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 31 Jan 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
- NCT03368352
- Acronym / sponsor ID
- 170200
- Keywords
- Melatonin, Altitude, Sleep, Ventilation, Cognition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 4 Jul 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 11 Dec 2017 (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. 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Normoxia | No intervention | –Sleep in normal room air with no drug |
| Hypoxia with Placebo | Placebo comparator | Other: HypoxiaSleep in hypoxic tent after taking Placebo 1 hour before bed. |
| Hypoxia with Melatonin | Experimental | Dietary Supplement: MelatoninSleep in hypoxic tent after taking 5 mg Melatonin before bed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| MelatoninDietary supplement melatonin | Dietary supplement | Hypoxia with Melatonin |
| HypoxiaSleep in a hypoxic tent simulating high altitude | Other | Hypoxia with Placebo |
Primary outcome
Neurocognitive function
Time frame: 30 minutes after arousal from sleep
Stroop-color word test median number of errors. Higher numbers indicate worse performance.
Endothelial function
Time frame: 5 minutes after arousal from sleep
Reactive hypermedia index via EndoPat
Lipid peroxidation in serum
Time frame: immediately after arousal from sleep
Concentration of Malondialdehyde in serum samples
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
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 31 Jan 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Melatonin and Hypoxia in people with Altitude Hypoxia and Ventilation, run by University of California, San Diego 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 1 inclusion and 13 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 31 Jan 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neurocognitive function (time frame: 30 minutes after arousal from sleep). The study lists 4 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 31 Jan 2019.