Obstructive Sleep Apnea Clinical Trial
Official title:
Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study
The purpose of this study is to determine the effects of the anticholinesterase drug donepezil on sleep apnea patients. Sleep structure and respiratory parameters will be analyzed by polysomnography.
Cholinergic activity also influences the upper airway opening via central and peripheral
mechanisms. Decreased thalamic pontine cholinergic projections may affect respiratory drive
leading to both central and obstructive apnea at least in certain degenerative conditions.In
contrast to the prolific literature on physical and surgical treatments for sleep apnea
there is a dearth of effective pharmacological approaches.Most drugs previously tested for
this purpose acted upon monoaminergic and adenosinergic systems and showed unsuccessful or
ambiguous results.A previous study showed that donepezil treatment improved apnea-hypopnea
index and oxygen saturation in patients with Alzheimer's disease. Treatment also increased
REM sleep duration and reduced ADAS-cog scores.Based on these facts we hypothesize that
donepezil treatment may be beneficial for sleep apnea patients.
Intervention: Patients will be administered donepezil or placebo. The study has a
randomized, double-blind placebo-controlled design. Complete polysomnography will be
performed at baseline, after 28 days of drug or placebo treatment, after 15 days drug or
placebo washout and after 28 days of CPAP treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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