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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00912457
Other study ID # CEP0043/07
Secondary ID
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


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
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