Effects of Melatonin in Untreated Obstructive Sleep Apnea
Status: | Terminated |
---|---|
Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 30 - 60 |
Updated: | 2/2/2019 |
Start Date: | April 1, 2018 |
End Date: | October 1, 2018 |
Does Melatonin Improve Neurocognitive Function, Cardiovascular Outcomes and Control of Breathing in Untreated Obstructive Sleep Apnea?
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.
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials