Summary

for people ages 30-60 (full criteria)
study started
estimated completion:

Description

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.

Official Title

Does Melatonin Improve Neurocognitive Function, Cardiovascular Outcomes and Control of Breathing in Untreated Obstructive Sleep Apnea?

Details

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.

Keywords

Obstructive Sleep Apnea Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Melatonin

Eligibility

You can join if…

Open to people ages 30-60

  • moderate-severe OSA (AHI ≥15/hr)

You CAN'T join 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.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Naomi Deacon
ID
NCT03492736
Phase
Phase 1
Study Type
Interventional
Last Updated