Effects of Melatonin in Untreated Obstructive Sleep Apnea

Stopped early · Early Phase 1 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT03492736

Run by

Naomi Deacon

People needed

1

Starts

2018-04-01

Expected to finish

2018-10-01

Last updated by the study team

2019-01-31

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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