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Donepezil Treatment for Sleep Apnea Patients (doneapnea)

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ClinicalTrials.gov Identifier: NCT00912457
Recruitment Status : Unknown
Verified June 2009 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was:  Recruiting
First Posted : June 3, 2009
Last Update Posted : June 3, 2009
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: donepezil Drug: placebo Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study
Study Start Date : March 2007
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: Donepezil
Donepezil-treated sleep apnea patients
 Drug: donepezil
donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days
Other Name: Eranz, Aricept
Placebo Comparator: Placebo
Placebo-treated sleep apnea patients
 Drug: placebo
placebo 1 p/day for 28 days
Other Name: Non-active substance


Outcome Measures
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Primary Outcome Measures :
  1. Polysomnography parameters: respiratory parameters, sleep structure [ Time Frame: baseline, 28 days, 15 days, 28 days ]

Secondary Outcome Measures :
  1. Epworth Sleepiness Scale [ Time Frame: baseline, 28 days, 15 days, 28 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00912457


Contacts
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Contact: Lucia Sukys Claudino, MD (55-48)-9129-7576 lucia@neuromeddiagnosticos.com.br
Contact: Walter Moraes, MD (55-11)-5573-9238 walter.moraes@afip.com.br

Locations
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Brazil
Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia Recruiting
Sao Paulo, Brazil, 04020-060
Contact: Lucia Sukys-Claudino, MD    (55-48)-9129-7576    lucia@neuromeddiagnosticos.com.br   
Contact: Walter Moraes, MD, PhD    (55-11)-5573-9238    walter.moraes@afip.com.br   
Principal Investigator: Sergio Tufik, MD, PhD         
Sub-Investigator: Dalva Poyares, MD, PhD         
Sponsors and Collaborators
Associacao Fundo de Incentivo a Psicofarmcologia
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Walter Moraes, MD PhD Associacao Fundo de Incentivo a Psicofarmcologia
Study Director: Lucia Sukys-Claudino, MD AFIP / UNIFESP
Study Chair: Dalva Poyares, MD, PhD AFIP/ UNIFESP
Study Chair: Sergio Tufik, MD, PhD AFIP/ UNIFESP
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Walter Andre dos Santos Moraes, AFIP
ClinicalTrials.gov Identifier: NCT00912457    
Other Study ID Numbers: CEP0043/07
First Posted: June 3, 2009    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009
Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
sleep apnea
donepezil
pharmacological
cholinergic
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
 Nervous System Diseases
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents