Does Melatonin Improve Neurocognitive Function, Cardiovascular Outcomes and Control of Breathing in Untreated Obstructive Sleep Apnea?
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- PHQ-9 score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 60 Years (Adult)
- Sex
- All
- 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
- •smokers (quit ≥ 1 year ago acceptable)
- •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.
Arms & Interventions
Placebo
30 days placebo taken nightly 1 hour before bed
Intervention: Placebo (Other)
Melatonin
30 days 10mg Melatonin taken nightly 1 hour before bed
Intervention: Melatonin (Dietary Supplement)
Outcomes
Primary Outcomes
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 Outcomes
- Reactive Hyperemia Index(baseline versus on the 30th day of treatment)
Investigators
Naomi Deacon
Research Scholar
University of California, San Diego