Donepezil Treatment for Sleep Apnea Patients (doneapnea)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT00912457
First received: June 2, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Primary Outcome Measures:
  • Polysomnography parameters: respiratory parameters, sleep structure [ Time Frame: baseline, 28 days, 15 days, 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912457

Contacts
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
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
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 July 22, 2014