NCT00912457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 3, 2009

Status Verified

June 1, 2009

Enrollment Period

2.8 years

First QC Date

June 2, 2009

Last Update Submit

June 2, 2009

Conditions

Obstructive Sleep Apnea

Keywords

sleep apneadonepezilpharmacologicalcholinergic

Outcome Measures

Primary Outcomes (1)

  • Polysomnography parameters: respiratory parameters, sleep structure

    baseline, 28 days, 15 days, 28 days

Secondary Outcomes (1)

  • Epworth Sleepiness Scale

    baseline, 28 days, 15 days, 28 days

Study Arms (2)

Donepezil

EXPERIMENTAL

Donepezil-treated sleep apnea patients

Drug: donepezil

Placebo

PLACEBO COMPARATOR

Placebo-treated sleep apnea patients

Drug: placebo

Interventions

donepezilDRUG

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

Also known as: Eranz, Aricept
Donepezil
placeboDRUG

placebo 1 p/day for 28 days

Also known as: Non-active substance
Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of obstructive sleep apnea according to American Academy of Sleep Medicine criteria

You may not qualify if:

  • body mass index \> 40
  • use of psychoactive drugs
  • presence of neurological, cardiological and pulmonary diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Sono / Associacao Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, 04020-060, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22281004DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Interventions

Donepezil

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Walter Moraes, MD PhD

    Associacao Fundo de Incentivo a Psicofarmcologia

    PRINCIPAL INVESTIGATOR

  • Lucia Sukys-Claudino, MD

    AFIP / UNIFESP

    STUDY DIRECTOR

  • Dalva Poyares, MD, PhD

    AFIP/ UNIFESP

    STUDY CHAIR

  • Sergio Tufik, MD, PhD

    AFIP/ UNIFESP

    STUDY CHAIR

Central Study Contacts

Lucia Sukys Claudino, MD

CONTACT

(55-48)-9129-7576lucia@neuromeddiagnosticos.com.br

Walter Moraes, MD

CONTACT

(55-11)-5573-9238walter.moraes@afip.com.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 3, 2009

Study Start

March 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 3, 2009

Record last verified: 2009-06

Locations

BR(1)