Donepezil Treatment for Sleep Apnea Patients (doneapnea)

June 2, 2009 updated by: Associacao Fundo de Incentivo a Psicofarmcologia

Donepezil Treatment for Sleep Apnea Patients: A Double Blind Placebo-Controlled Study

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.

Study Overview

Status

Unknown

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04020-060
        • Recruiting
        • Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sergio Tufik, MD, PhD
        • Sub-Investigator:
          • Dalva Poyares, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: donepezil
donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days
Other Names:
  • Eranz, Aricept
Placebo Comparator: Placebo
Placebo-treated sleep apnea patients
Drug: placebo
placebo 1 p/day for 28 days
Other Names:
  • Non-active substance

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

This is where you will find people and organizations involved with this study.

Sponsor

Associacao Fundo de Incentivo a Psicofarmcologia

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 2, 2009

First Posted (Estimate)

June 3, 2009

Study Record Updates

Last Update Posted (Estimate)

June 3, 2009

Last Update Submitted That Met QC Criteria

June 2, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

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