Donepezil Treatment for Sleep Apnea Patients (doneapnea)
Recruitment status was Recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea |
Drug: donepezil Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study |
- Polysomnography parameters: respiratory parameters, sleep structure [ Time Frame: baseline, 28 days, 15 days, 28 days ] [ Designated as safety issue: Yes ]
- Epworth Sleepiness Scale [ Time Frame: baseline, 28 days, 15 days, 28 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 30 Years to 60 Years |
| Genders 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
Contacts and Locations| 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 |
More Information
No publications provided by Associacao Fundo de Incentivo a Psicofarmcologia
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Walter Andre dos Santos Moraes, AFIP |
| ClinicalTrials.gov Identifier: | NCT00912457 History of Changes |
| Other Study ID Numbers: | CEP0043/07 |
| Study First Received: | June 2, 2009 |
| Last Updated: | June 2, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
|
sleep apnea donepezil pharmacological cholinergic |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013