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Donepezil Treatment for Sleep Apnea Patients (doneapnea)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia

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.

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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

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00912457

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Contact: Lucia Sukys Claudino, MD (55-48)-9129-7576
Contact: Walter Moraes, MD (55-11)-5573-9238

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Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia Recruiting
Sao Paulo, Brazil, 04020-060
Contact: Lucia Sukys-Claudino, MD    (55-48)-9129-7576   
Contact: Walter Moraes, MD, PhD    (55-11)-5573-9238   
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
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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Walter Andre dos Santos Moraes, AFIP 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
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents