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Effects of Melatonin in Untreated Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03492736
Recruitment Status : Terminated (PI leaving the laboratory)
First Posted : April 10, 2018
Last Update Posted : January 31, 2019
Information provided by (Responsible Party):
Naomi Deacon, University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Dietary Supplement: Melatonin Other: Placebo Early Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, parallel
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Does Melatonin Improve Neurocognitive Function, Cardiovascular Outcomes and Control of Breathing in Untreated Obstructive Sleep Apnea?
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin
30 days 10mg Melatonin taken nightly 1 hour before bed
Dietary Supplement: Melatonin
30 days 10mg Melatonin taken nightly 1 hour before bed

Placebo Comparator: Placebo
30 days placebo taken nightly 1 hour before bed
Other: Placebo
30 days placebo taken nightly 1 hour before bed

Primary Outcome Measures :
  1. PHQ-9 score [ Time Frame: baseline versus on the 30th day of treatment ]
    9 Questions relating to depressive symptoms. Answers to each question rank from 0-3. Minimum total score = 0, maximum total score = 27, with >=10 indicating clinically significant moderate severity depressive symptoms.

Secondary Outcome Measures :
  1. Reactive Hyperemia Index [ Time Frame: baseline versus on the 30th day of treatment ]
    Endothelial function is calculated as the ratio between the magnitude of the mean post-occlusion pulse wave amplitude and mean baseline pulse wave amplitude.

Other Outcome Measures:
  1. Hypoxic ventilatory response [ Time Frame: baseline versus on the 30th day of treatment ]
    change in ventilation per change in expiratory CO2 during sustained hypoxia

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Groups will be matched for gender, age and BMI
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492736

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United States, California
University of California, San Diego
San Diego, California, United States, 92093
Sponsors and Collaborators
Naomi Deacon
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Study Director: Naomi L Deacon, Ph.D. UCSD Pulmonary and Sleep Medicine
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Responsible Party: Naomi Deacon, Research Scholar, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03492736    
Other Study ID Numbers: 180013
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants