Effects of Melatonin in Untreated Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-10-01

Brief Summary

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The investigators have previously shown that 1 week of 10mg Melatonin improves sleep consolidation in untreated obstructive sleep apnea (OSA) patients. This study aims to extend on those findings to determine if longer treatment of Melatonin improves other outcomes in untreated OSA patients.

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Detailed Description

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Intermittent hypoxia (low oxygen), sleep fragmentation and restriction are characteristic of obstructive sleep apnea (OSA) and cause mental deficits and cardiovascular disease (CVD). Melatonin (MLT) is a hormone with sleep promoting properties and the investigators have found 7 days 10mg MLT treatment significantly increases sleep consolidation in untreated OSA. Thus, melatonin could improve mental function. MLT also has potent antioxidant, anti-inflammatory and anti-hypertensive properties. In humans with CVD and metabolic disorder exogenous MLT improves a wide range of cardio-metabolic outcomes. In rat models of OSA, MLT completely blocks intermittent hypoxia induced cardiovascular damage and brain cell death. Intermittent hypoxia also induces lasting changes in the neural control of breathing, which worsens OSA. Experimentally antioxidants block the induction of changes to neural control of breathing. Thus MLT may also normalize the control of breathing and reduce the severity of OSA. Given these findings, the hypothesis is that MLT will improve mental function, cardiovascular outcomes and control of breathing in untreated OSA.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled, parallel

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Melatonin

30 days 10mg Melatonin taken nightly 1 hour before bed

Group Type EXPERIMENTAL

Melatonin

Intervention Type DIETARY_SUPPLEMENT

30 days 10mg Melatonin taken nightly 1 hour before bed

Placebo

30 days placebo taken nightly 1 hour before bed

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

30 days placebo taken nightly 1 hour before bed

Interventions

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Melatonin

30 days 10mg Melatonin taken nightly 1 hour before bed

Intervention Type DIETARY_SUPPLEMENT

Placebo

30 days placebo taken nightly 1 hour before bed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* moderate-severe OSA (AHI ≥15/hr)

Exclusion Criteria

* non-English speakers (due to necessity to complete neurocognitive testing)
* other sleep disorders
* history of driving or other accidents due to sleepiness or an Epworth score (ESS)\> 18
* pregnant
* smokers (quit ≥ 1 year ago acceptable)
* diabetes
* cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease
* Substantial alcohol (\>3oz/day) or use of illicit drugs
* psychiatric disorders (other than depression or anxiety)
* current MLT use or use within last 6 months
* beta blockers, central nervous system depressants or stimulants, anti-inflammatories, anticoagulants, immunosuppressants, vitamins, antioxidants.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No