Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2007-03-31
2009-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Donepezil
Donepezil-treated sleep apnea patients
donepezil
donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days
Placebo
Placebo-treated sleep apnea patients
placebo
placebo 1 p/day for 28 days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* use of psychoactive drugs
* presence of neurological, cardiological and pulmonary diseases
30 Years
60 Years
MALE
No
Sponsors
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Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
Associacao Fundo de Incentivo a Psicofarmcologia
OTHER
Responsible Party
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AFIP
Principal Investigators
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Walter Moraes, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Associacao Fundo de Incentivo a Psicofarmcologia
Lucia Sukys-Claudino, MD
Role: STUDY_DIRECTOR
AFIP / UNIFESP
Dalva Poyares, MD, PhD
Role: STUDY_CHAIR
AFIP/ UNIFESP
Sergio Tufik, MD, PhD
Role: STUDY_CHAIR
AFIP/ UNIFESP
Locations
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Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Sukys-Claudino L, Moraes W, Guilleminault C, Tufik S, Poyares D. Beneficial effect of donepezil on obstructive sleep apnea: a double-blind, placebo-controlled clinical trial. Sleep Med. 2012 Mar;13(3):290-6. doi: 10.1016/j.sleep.2011.09.014. Epub 2012 Jan 26.
Other Identifiers
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CEP0043/07
Identifier Type: -
Identifier Source: org_study_id
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