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Effects of Melatonin in Untreated Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
Naomi Deacon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

30 days 10mg Melatonin taken nightly 1 hour before bed

30 days placebo taken nightly 1 hour before bed

Outcomes

Primary Outcome Measures

PHQ-9 score
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

Reactive Hyperemia Index
Endothelial function is calculated as the ratio between the magnitude of the mean post-occlusion pulse wave amplitude and mean baseline pulse wave amplitude.

Full Information

First Posted
April 2, 2018
Last Updated
January 29, 2019
Sponsor
Naomi Deacon
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1. Study Identification

Unique Protocol Identification Number
NCT03492736
Brief Title
Effects of Melatonin in Untreated Obstructive Sleep Apnea
Official Title
Does Melatonin Improve Neurocognitive Function, Cardiovascular Outcomes and Control of Breathing in Untreated Obstructive Sleep Apnea?
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
PI leaving the laboratory
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Naomi Deacon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, parallel
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
30 days 10mg Melatonin taken nightly 1 hour before bed
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30 days placebo taken nightly 1 hour before bed
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
30 days 10mg Melatonin taken nightly 1 hour before bed
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
30 days placebo taken nightly 1 hour before bed
Primary Outcome Measure Information:
Title
PHQ-9 score
Description
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.
Time Frame
baseline versus on the 30th day of treatment
Secondary Outcome Measure Information:
Title
Reactive Hyperemia Index
Description
Endothelial function is calculated as the ratio between the magnitude of the mean post-occlusion pulse wave amplitude and mean baseline pulse wave amplitude.
Time Frame
baseline versus on the 30th day of treatment
Other Pre-specified Outcome Measures:
Title
Hypoxic ventilatory response
Description
change in ventilation per change in expiratory CO2 during sustained hypoxia
Time Frame
baseline versus on the 30th day of treatment

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Groups will be matched for gender, age and BMI
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi L Deacon, Ph.D.
Organizational Affiliation
UCSD Pulmonary and Sleep Medicine
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Melatonin in Untreated Obstructive Sleep Apnea

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