Donepezil Treatment for Sleep Apnea Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: donepezil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of obstructive sleep apnea according to American Academy of Sleep Medicine criteria Exclusion Criteria: body mass index > 40 use of psychoactive drugs presence of neurological, cardiological and pulmonary diseases

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donepezil<br>Donepezil-treated sleep apnea patients | Drug: donepezil<br>* donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days<br>* Other names: Eranz, Aricept;|
| Placebo Comparator: Placebo<br>Placebo-treated sleep apnea patients | Drug: placebo<br>* placebo 1 p/day for 28 days<br>* Other names: Non-active substance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography parameters: respiratory parameters, sleep structure |  | baseline, 28 days, 15 days, 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale |  | baseline, 28 days, 15 days, 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, donepezil, pharmacological, cholinergic