NCT03299257

Brief Summary

It is a randomized, double-blind, single-center, 30-day study. Patients aged 35-60 years, with apnea and hypopnea index and respiratory disturbance index normalized with CPAP, and Epworth Sleepiness Scale\> 11. Patients undergo baseline and CPAP titration polysomnography, liquor and blood collection, Multiple Sleep Latency Test, anxiety and depression and cognitive assessments.

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
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2018

Shorter than P25 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

First Submitted

Initial submission to the registry

May 11, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

July 6, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2019

Completed
Last Updated

June 27, 2018

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

May 11, 2017

Last Update Submit

June 26, 2018

Conditions

OSASleepiness

Keywords

OSACPAPsleepinessdonepezil

Outcome Measures

Primary Outcomes (2)

  • objective excessive daytime sleepiness

    Maintenance Wakefulness Test

    40 days

  • subjective excessive daytime sleepiness

    Epworth Sleepiness Scale

    40 days

Secondary Outcomes (1)

  • cognitive improvement (executive functions)

    40 days

Study Arms (2)

donepezil treatment

ACTIVE COMPARATOR

donepezil with 10 mg will be administered for 30 days.

Drug: donepezil treatment

placebo treatment

PLACEBO COMPARATOR

placebo with 10 mg placebo will be administered for 30 days.

Drug: donepezil treatment

Interventions

donepezil treatmentDRUG

30-day donepezil treatment

donepezil treatmentplacebo treatment

Eligibility Criteria

Age35 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both gender, Age between 35 and 65 years;
  • Confirmed diagnosis of moderate to severe OSA;
  • Treatment with CPAP for at least six months;
  • Persistent sleepiness with daily CPAP use compliance \> 5 hours per night.

You may not qualify if:

  • Neurological or psychiatric diseases;
  • Chronic use of psychoactive drugs, other sleep disorders than OSA, visual defficiency, illiteracy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Sono

São Paulo, 04024-002, Brazil

Location

MeSH Terms

Conditions

Sleepiness

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ksdy Maiara Werli, Psy

CONTACT

+55-11-958491512ksdymaiara@yahoo.com.br

Dalva Poyares, MD

CONTACT

+55-11-985937418poyares@unifesp.br

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
donepezil and placebo will be dispensed to volunteers in similar pills and numbered boxes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, parallel groups, 30-day trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD Professor

Study Record Dates

First Submitted

May 11, 2017

First Posted

October 3, 2017

Study Start

July 6, 2018

Primary Completion

November 4, 2018

Study Completion

March 2, 2019

Last Updated

June 27, 2018

Record last verified: 2017-09

Locations

BR(1)