Donepezil Treatment for Sleep Apnea Patients

NCT ID: NCT00912457

Last Updated: 2009-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Donepezil

Donepezil-treated sleep apnea patients

Group Type EXPERIMENTAL

donepezil

Intervention Type DRUG

donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days

Placebo

Placebo-treated sleep apnea patients

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo 1 p/day for 28 days

Interventions

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donepezil

donepezil 5 mg/day for 14 days followed by donepezil 10 mg/day for 14 days

Intervention Type DRUG

placebo

placebo 1 p/day for 28 days

Intervention Type DRUG

Other Intervention Names

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Eranz, Aricept Non-active substance

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role lead

Responsible Party

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AFIP

Principal Investigators

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Walter Moraes, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Associacao Fundo de Incentivo a Psicofarmcologia

Lucia Sukys-Claudino, MD

Role: STUDY_DIRECTOR

AFIP / UNIFESP

Dalva Poyares, MD, PhD

Role: STUDY_CHAIR

AFIP/ UNIFESP

Sergio Tufik, MD, PhD

Role: STUDY_CHAIR

AFIP/ UNIFESP

Locations

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Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Lucia Sukys Claudino, MD

Role: CONTACT

(55-48)-9129-7576

Walter Moraes, MD

Role: CONTACT

(55-11)-5573-9238

Facility Contacts

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Lucia Sukys-Claudino, MD

Role: primary

(55-48)-9129-7576

Walter Moraes, MD, PhD

Role: backup

(55-11)-5573-9238

References

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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.

Reference Type DERIVED
PMID: 22281004 (View on PubMed)

Other Identifiers

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CEP0043/07

Identifier Type: -

Identifier Source: org_study_id

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