Effects of Melatonin in Untreated Obstructive Sleep Apnea

Naomi Deacon

Status and phase

Terminated

Early Phase 1

Conditions

Obstructive Sleep Apnea

Treatments

Dietary Supplement: Melatonin

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03492736

180013

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

30 to 60 years old

Volunteers

No 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.