- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00912457
Donepezil Treatment for Sleep Apnea Patients (doneapnea)
Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Lucia Sukys Claudino, MD
- Phone Number: (55-48)-9129-7576
- Email: lucia@neuromeddiagnosticos.com.br
Study Contact Backup
- Name: Walter Moraes, MD
- Phone Number: (55-11)-5573-9238
- Email: walter.moraes@afip.com.br
Study Locations
-
-
-
Sao Paulo, Brazil, 04020-060
- Recruiting
- Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia
-
Contact:
- Lucia Sukys-Claudino, MD
- Phone Number: (55-48)-9129-7576
- Email: lucia@neuromeddiagnosticos.com.br
-
Contact:
- Walter Moraes, MD, PhD
- Phone Number: (55-11)-5573-9238
- Email: walter.moraes@afip.com.br
-
Principal Investigator:
- Sergio Tufik, MD, PhD
-
Sub-Investigator:
- Dalva Poyares, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Donepezil
Donepezil-treated sleep apnea patients
|
donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days
Other Names:
|
Placebo Comparator: Placebo
Placebo-treated sleep apnea patients
|
placebo 1 p/day for 28 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Polysomnography parameters: respiratory parameters, sleep structure
Time Frame: baseline, 28 days, 15 days, 28 days
|
baseline, 28 days, 15 days, 28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Epworth Sleepiness Scale
Time Frame: baseline, 28 days, 15 days, 28 days
|
baseline, 28 days, 15 days, 28 days
|
Collaborators and Investigators
Collaborators
Investigators
- 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 and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Apnea
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Nootropic Agents
- Cholinesterase Inhibitors
- Donepezil
Other Study ID Numbers
- CEP0043/07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
ResMedCompletedObstructive Sleep Apnea (OSA)United States, Australia
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
Clinical Trials on donepezil
-
Eisai Inc.Eisai LimitedCompleted
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Corium, Inc.CompletedAlzheimer DiseaseUnited States
-
Samsung Medical CenterEisai Korea Inc.CompletedDementia | Alzheimer's DiseaseKorea, Republic of
-
Eisai Co., Ltd.CompletedDementia With Lewy Bodies (DLB)Japan
-
Eisai Inc.PfizerTerminatedCognitive Dysfunction | Down SyndromeUnited States
-
Eisai Inc.PfizerTerminatedCognitive Dysfunction | Down SyndromeUnited States
-
Eisai Inc.CompletedMigraine HeadacheUnited States
-
The First Affiliated Hospital with Nanjing Medical...Unknown
-
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Completed