Trial | NCT00912457  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    donepezil ...

  • Study Participants

    60
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.
Study Started
Mar 31
2007
Primary Completion
Dec 31
2009
Anticipated
Study Completion
Dec 31
2009
Anticipated
Last Update
Jun 03
2009
Estimate

Drug donepezil

donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days

  • Other names: Eranz, Aricept

Drug placebo

placebo 1 p/day for 28 days

  • Other names: Non-active substance

Donepezil Experimental

Donepezil-treated sleep apnea patients

Placebo Placebo Comparator

Placebo-treated sleep apnea patients

Criteria 

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
No Results Posted