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

NCT ID: NCT03368352

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-04
• Study Completion Date: 2018-12-20

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.

Conditions

Altitude Hypoxia; Ventilation; Sleep; Oxidative Stress; Neurocognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Normoxia

Sleep in normal room air with no drug

Group Type: NO_INTERVENTION

No interventions assigned to this group

Hypoxia with Placebo

Sleep in hypoxic tent after taking Placebo 1 hour before bed.

Group Type: PLACEBO_COMPARATOR

Hypoxia

Intervention Type: OTHER

Sleep in a hypoxic tent simulating high altitude

Hypoxia with Melatonin

Sleep in hypoxic tent after taking 5 mg Melatonin before bed.

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement melatonin

Interventions

Melatonin

Dietary supplement melatonin

Intervention Type: DIETARY_SUPPLEMENT

Hypoxia

Sleep in a hypoxic tent simulating high altitude

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Naomi Deacon

Research Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UCSD Sleep Lab

San Diego, California, United States

Countries

United States

Other Identifiers

170200

Identifier Type: -

Identifier Source: org_study_id