Donepezil Treatment for Sleep Apnea Patients (doneapnea)
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
donepezil
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep apnea, donepezil, pharmacological, cholinergic
Eligibility 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
Sites / Locations
- Instituto do Sono / Associacao Fundo de Incentivo a PsicofarmacologiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Donepezil
Placebo
Arm Description
Donepezil-treated sleep apnea patients
Placebo-treated sleep apnea patients
Outcomes
Primary Outcome Measures
Polysomnography parameters: respiratory parameters, sleep structure
Secondary Outcome Measures
Epworth Sleepiness Scale
Full Information
NCT ID
NCT00912457
First Posted
June 2, 2009
Last Updated
June 2, 2009
Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00912457
Brief Title
Donepezil Treatment for Sleep Apnea Patients
Acronym
doneapnea
Official Title
Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
sleep apnea, donepezil, pharmacological, cholinergic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Donepezil
Arm Type
Experimental
Arm Description
Donepezil-treated sleep apnea patients
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-treated sleep apnea patients
Intervention Type
Drug
Intervention Name(s)
donepezil
Other Intervention Name(s)
Eranz, Aricept
Intervention Description
donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Non-active substance
Intervention Description
placebo 1 p/day for 28 days
Primary Outcome Measure Information:
Title
Polysomnography parameters: respiratory parameters, sleep structure
Time Frame
baseline, 28 days, 15 days, 28 days
Secondary Outcome Measure Information:
Title
Epworth Sleepiness Scale
Time Frame
baseline, 28 days, 15 days, 28 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucia Sukys Claudino, MD
Phone
(55-48)-9129-7576
Email
lucia@neuromeddiagnosticos.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Walter Moraes, MD
Phone
(55-11)-5573-9238
Email
walter.moraes@afip.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Moraes, MD PhD
Organizational Affiliation
Associacao Fundo de Incentivo a Psicofarmcologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lucia Sukys-Claudino, MD
Organizational Affiliation
AFIP / UNIFESP
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dalva Poyares, MD, PhD
Organizational Affiliation
AFIP/ UNIFESP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sergio Tufik, MD, PhD
Organizational Affiliation
AFIP/ UNIFESP
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia
City
Sao Paulo
ZIP/Postal Code
04020-060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucia Sukys-Claudino, MD
Phone
(55-48)-9129-7576
Email
lucia@neuromeddiagnosticos.com.br
First Name & Middle Initial & Last Name & Degree
Walter Moraes, MD, PhD
Phone
(55-11)-5573-9238
Email
walter.moraes@afip.com.br
First Name & Middle Initial & Last Name & Degree
Sergio Tufik, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dalva Poyares, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22281004
Citation
Sukys-Claudino L, Moraes W, Guilleminault C, Tufik S, Poyares D. Beneficial effect of donepezil on obstructive sleep apnea: a double-blind, placebo-controlled clinical trial. Sleep Med. 2012 Mar;13(3):290-6. doi: 10.1016/j.sleep.2011.09.014. Epub 2012 Jan 26.
Results Reference
derived
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Donepezil Treatment for Sleep Apnea Patients
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