Effects of Melatonin in Untreated Obstructive Sleep Apnea

NCT03492736 | Terminated Early Phase 1

• 1 other identifier: 180013
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline versus on the 30th day of treatment

Secondary Outcomes (1)

• Reactive Hyperemia Index

  baseline versus on the 30th day of treatment

Other Outcomes (1)

• Hypoxic ventilatory response

  baseline versus on the 30th day of treatment

Study Arms (2)

Melatonin

EXPERIMENTAL

30 days 10mg Melatonin taken nightly 1 hour before bed

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

30 days placebo taken nightly 1 hour before bed

Other: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

30 days 10mg Melatonin taken nightly 1 hour before bed

Melatonin

Placebo OTHER

30 days placebo taken nightly 1 hour before bed

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Groups will be matched for gender, age and BMI
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• moderate-severe OSA (AHI ≥15/hr)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Naomi Deacon: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Naomi L Deacon, Ph.D.

  UCSD Pulmonary and Sleep Medicine

  STUDY DIRECTOR

Study Design

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

Model Details: Randomized, double-blind, placebo-controlled, parallel

Study Record Dates

• First Submitted: April 2, 2018
• First Posted: April 10, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)