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

NCT03368352 | Completed Early Phase 1

• 1 other identifier: 170200
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Melatonin; Altitude; Sleep; Ventilation; Cognition

Outcome Measures

Primary Outcomes (4)

• Neurocognitive function

  Stroop-color word test median number of errors. Higher numbers indicate worse performance.

  30 minutes after arousal from sleep

• Endothelial function

  Reactive hypermedia index via EndoPat

  5 minutes after arousal from sleep

• Lipid peroxidation in serum

  Concentration of Malondialdehyde in serum samples

  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

  1 hour after arousal from sleep

Study Arms (3)

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.

Other: Hypoxia

Hypoxia with Melatonin

EXPERIMENTAL

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

Dietary Supplement: Melatonin

Interventions

Melatonin DIETARY_SUPPLEMENT

Dietary supplement melatonin

Hypoxia with Melatonin

Hypoxia OTHER

Sleep in a hypoxic tent simulating high altitude

Hypoxia with Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Sleep Lab

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Altitude Sickness; Respiratory Aspiration; Cognition Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scholar

Model Details: Randomized, double-blind, placebo controlled

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 11, 2017
• Study Start: July 4, 2017
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)