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Donepezil, Residual Excessive Daytime Sleepiness, Obstructive Sleep Apnea

Donepezil for Residual Symptoms in CPAP Treated Obstructive Sleepapnea Patients: A Controlled Study

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03299257
Enrollment
36
Registered
2017-10-03
Start date
2018-07-06
Completion date
2019-03-02
Last updated
2018-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSA, Sleepiness

Keywords

OSA, CPAP, sleepiness, donepezil

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.

Interventions

DRUGdonepezil treatment

30-day donepezil treatment

Sponsors

Associação Fundo de Incentivo à Pesquisa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

donepezil and placebo will be dispensed to volunteers in similar pills and numbered boxes.

Intervention model description

Randomized, parallel groups, 30-day trial

Eligibility

Sex/Gender
ALL
Age
35 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
objective excessive daytime sleepiness40 daysMaintenance Wakefulness Test
subjective excessive daytime sleepiness40 daysEpworth Sleepiness Scale

Secondary

MeasureTime frameDescription
cognitive improvement (executive functions)40 daysstandard cognitive tests to evaluate executive functions

Countries

Brazil

Contacts

Primary ContactKsdy Maiara Werli, Psy
ksdymaiara@yahoo.com.br+55-11-958491512
Backup ContactDalva Poyares, MD
poyares@unifesp.br+55-11-985937418

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026