Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-28 @ 8:46 AM
Study NCT ID:
NCT00912457
Status:
UNKNOWN
Last Update Posted:
2009-06-03
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Donepezil Treatment for Sleep Apnea Patients
Sponsor:
Associacao Fundo de Incentivo a Psicofarmcologia
Organization:
Study Overview
Official Title:
Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
doneapnea
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: