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Trial record 35 of 332 for:    DONEPEZIL

Donepezil, Residual Excessive Daytime Sleepiness, Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299257
Recruitment Status : Unknown
Verified September 2017 by Dalva Poyares, Associação Fundo de Incentivo à Pesquisa.
Recruitment status was:  Not yet recruiting
First Posted : October 3, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dalva Poyares, Associação Fundo de Incentivo à Pesquisa

Tracking Information
First Submitted Date  ICMJE May 11, 2017
First Posted Date  ICMJE October 3, 2017
Last Update Posted Date June 27, 2018
Estimated Study Start Date  ICMJE July 6, 2018
Estimated Primary Completion Date November 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • objective excessive daytime sleepiness [ Time Frame: 40 days ]
    Maintenance Wakefulness Test
  • subjective excessive daytime sleepiness [ Time Frame: 40 days ]
    Epworth Sleepiness Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03299257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
cognitive improvement (executive functions) [ Time Frame: 40 days ]
standard cognitive tests to evaluate executive functions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Donepezil, Residual Excessive Daytime Sleepiness, Obstructive Sleep Apnea
Official Title  ICMJE Donepezil for Residual Symptoms in CPAP Treated Obstructive Sleepapnea Patients: A Controlled Study
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.
Detailed Description

Obstructive Sleep Apnea (OSA) is a sleep-disordered breathing characterized by recurrent episodes of total or partial obstruction of the upper airway during sleep, which can lead to cognitive, metabolic and cardiovascular consequences. More recently, OSA has been associated with worsening Alzheimer's disease symptoms. Resolving respiratory events during sleep often has a beneficial impact on these consequences. However, even after adequate and optimized treatment with continuous positive airway pressure (CPAP), about 6 to 10% of patients still remain sleepy. Given the high prevalence of OSA, this percentage represents a large number of under-treated and at-risk individuals. This residual excessive sleepiness (RES) may be related to comorbidities and cognitive alterations. Its physiopathology is still unknown. A few studies have tested modafinil as an adjunct treatment for RES patients. Since a) CPAP is ineffective in patients with RES; b) previous studies suggest some benefit with wake promoters; and c) cognitive impairment has also been reported associated with RES; the hypothesis of the present study is that donepezil improves alertness and cognition in patients with OSA and RES, evidencing the role of the cholinergic system in the pathophysiology of RES.

Objective: To evaluate the effects of donepezil on RES in adult patients treated with CPAP.

Thirty-six patients diagnosed with OSA and RES are estimated to be included. Participants will be treated with CPAP for more than 6 months with a mean use greater than 5 hours per day. After blood and cerebrospinal fluid collection, patients will be randomized into 2 groups of 30 days of treatment with donepezil or placebo. RES will be evaluated by the vigilance test and the Epworth Sleepiness Scale.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, parallel groups, 30-day trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
donepezil and placebo will be dispensed to volunteers in similar pills and numbered boxes.
Primary Purpose: Treatment
Condition  ICMJE
  • OSA
  • Sleepiness
Intervention  ICMJE Drug: donepezil treatment
30-day donepezil treatment
Study Arms  ICMJE
  • Active Comparator: donepezil treatment
    donepezil with 10 mg will be administered for 30 days.
    Intervention: Drug: donepezil treatment
  • Placebo Comparator: placebo treatment
    placebo with 10 mg placebo will be administered for 30 days.
    Intervention: Drug: donepezil treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 27, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2, 2019
Estimated Primary Completion Date November 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Neurological or psychiatric diseases;
  • Chronic use of psychoactive drugs, other sleep disorders than OSA, visual defficiency, illiteracy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03299257
Other Study ID Numbers  ICMJE RES12
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dalva Poyares, Associação Fundo de Incentivo à Pesquisa
Study Sponsor  ICMJE Associação Fundo de Incentivo à Pesquisa
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Associação Fundo de Incentivo à Pesquisa
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP