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. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea | Drug: donepezil Drug: placebo | Phase 4 |
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 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 |

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 |
- Polysomnography parameters: respiratory parameters, sleep structure [ Time Frame: baseline, 28 days, 15 days, 28 days ]
- Epworth Sleepiness Scale [ Time Frame: baseline, 28 days, 15 days, 28 days ]

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.
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

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
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 |
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 |
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 |
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 |
sleep apnea donepezil pharmacological cholinergic |
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 |