Donepezil Treatment for Sleep Apnea Patients

Obstructive Sleep Apnea Clinical Trial

— doneapnea  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00912457
• Other study ID #: CEP0043/07
• Status: Recruiting
• Phase: Phase 4
• First received: June 2, 2009
• Last updated: June 2, 2009
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: Associacao Fundo de Incentivo a Psicofarmcologia
• Contact: Lucia Sukys Claudino, MD
• Phone: (55-48)-9129-7576
• Email: lucia[@]neuromeddiagnosticos.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• donepezil
donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days
• placebo
placebo 1 p/day for 28 days

Locations

Country	Name	City	State
Brazil	Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Associacao Fundo de Incentivo a Psicofarmcologia	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography parameters: respiratory parameters, sleep structure		baseline, 28 days, 15 days, 28 days	Yes
Secondary	Epworth Sleepiness Scale		baseline, 28 days, 15 days, 28 days	Yes