NCT00912457

Donepezil Treatment for Sleep Apnea Patients

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Associacao Fundo de Incentivo a Psicofarmcologia · Academic / Other
• Sex: Male
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	donepezil	donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days
DRUG	placebo	placebo 1 p/day for 28 days

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-06-03
• Last updated: 2009-06-03

Locations

1 site across 1 country: Brazil