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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. 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
Information provided by (Responsible Party):
Dalva Poyares, Associação Fundo de Incentivo à Pesquisa

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.

Condition or disease Intervention/treatment Phase
OSA Sleepiness Drug: donepezil treatment Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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
Official Title: Donepezil for Residual Symptoms in CPAP Treated Obstructive Sleepapnea Patients: A Controlled Study
Estimated Study Start Date : July 6, 2018
Estimated Primary Completion Date : November 4, 2018
Estimated Study Completion Date : March 2, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: donepezil treatment
donepezil with 10 mg will be administered for 30 days.
Drug: donepezil treatment
30-day donepezil treatment

Placebo Comparator: placebo treatment
placebo with 10 mg placebo will be administered for 30 days.
Drug: donepezil treatment
30-day donepezil treatment

Primary Outcome Measures :
  1. objective excessive daytime sleepiness [ Time Frame: 40 days ]
    Maintenance Wakefulness Test

  2. subjective excessive daytime sleepiness [ Time Frame: 40 days ]
    Epworth Sleepiness Scale

Secondary Outcome Measures :
  1. cognitive improvement (executive functions) [ Time Frame: 40 days ]
    standard cognitive tests to evaluate executive functions

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03299257

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Contact: Ksdy Maiara Werli, Psy +55-11-958491512
Contact: Dalva Poyares, MD +55-11-985937418

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Instituto do Sono
Sao Paulo, Brazil, 04024-002
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
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Responsible Party: Dalva Poyares, MD Professor, Associação Fundo de Incentivo à Pesquisa Identifier: NCT03299257    
Other Study ID Numbers: RES12
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Dalva Poyares, Associação Fundo de Incentivo à Pesquisa:
Additional relevant MeSH terms:
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Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents