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

Primary Purpose

Altitude Hypoxia, Ventilation, Sleep

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Melatonin

Hypoxia

About this trial

This is an interventional basic science trial for Altitude Hypoxia focused on measuring Melatonin, Altitude, Sleep, Ventilation, Cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

UCSD Sleep Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Experimental

Arm Label

Normoxia

Hypoxia with Placebo

Hypoxia with Melatonin

Arm Description

Sleep in normal room air with no drug

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

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

Outcomes

Primary Outcome Measures

Neurocognitive function

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

Endothelial function

Reactive hypermedia index via EndoPat

Lipid peroxidation in serum

Concentration of Malondialdehyde in serum samples

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03368352

First Posted

November 20, 2017

Last Updated

January 29, 2019

Sponsor

University of California, San Diego

1. Study Identification

Unique Protocol Identification Number

NCT03368352

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

July 4, 2017 (Actual)

Primary Completion Date

December 20, 2018 (Actual)

Study Completion Date

December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Melatonin, Altitude, Sleep, Ventilation, Cognition

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Model Description

Randomized, double-blind, placebo controlled

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normoxia

Arm Type

No Intervention

Arm Description

Sleep in normal room air with no drug

Arm Title

Hypoxia with Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Hypoxia with Melatonin

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Melatonin

Intervention Description

Dietary supplement melatonin

Intervention Type

Other

Intervention Name(s)

Hypoxia

Intervention Description

Sleep in a hypoxic tent simulating high altitude

Primary Outcome Measure Information:

Title

Neurocognitive function

Description

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

Time Frame

30 minutes after arousal from sleep

Title

Endothelial function

Description

Reactive hypermedia index via EndoPat

Time Frame

5 minutes after arousal from sleep

Title

Lipid peroxidation in serum

Description

Concentration of Malondialdehyde in serum samples

Time Frame

immediately after arousal from sleep

Title

Hypercapnic hypoxic ventilatory sensitivity

Description

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

Time Frame

1 hour after arousal from sleep

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

UCSD Sleep Lab

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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