OSAPhase 4NCT03299257
Donepezil, Residual Excessive Daytime Sleepiness, Obstructive Sleep Apnea
A Phase 4 study testing donepezil treatment in people with OSA and Sleepiness, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- OSA, Sleepiness
- What is being tested?
- donepezil treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jul 2018to 2 Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Neurological or psychiatric diseases;
- Chronic use of psychoactive drugs, other sleep disorders than OSA, visual defficiency, illiteracy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Donepezil for Residual Symptoms in CPAP Treated Obstructive Sleepapnea Patients: A Controlled Study
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.
Read the 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.
- Conditions
- OSA, Sleepiness
- Being tested
- donepezil treatment
- Keywords
- OSA, CPAP, sleepiness, donepezil
- Medical subject headings
- Sleepiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donepezil treatmentDrug
30-day donepezil treatment
| Study group | Role | What they receive |
|---|---|---|
| donepezil treatment | Active comparator | donepezil with 10 mg will be administered for 30 days. Receives: Drug: donepezil treatment |
| placebo treatment | Placebo comparator | placebo with 10 mg placebo will be administered for 30 days. Receives: Drug: donepezil treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective excessive daytime sleepiness
Maintenance Wakefulness Test
Measured: 40 days
subjective excessive daytime sleepiness
Epworth Sleepiness Scale
Measured: 40 days
Secondary outcomes (1)
cognitive improvement (executive functions)
standard cognitive tests to evaluate executive functions
Measured: 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start6 Jul 2018 (estimated)
- Primary completion4 Nov 2018 (estimated)
- Study completion2 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel groups, 30-day trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalva Poyares, Associação Fundo de Incentivo à Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299257
- Sponsor's protocol ID
- RES12
- Status last verified
- Sep 2017
- First submitted
- 11 May 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donepezil for Residual Symptoms in CPAP Treated Obstructive Sleepapnea Patients: A Controlled Study
- ClinicalTrials.gov ID
- NCT03299257
- Acronym / sponsor ID
- RES12
- Conditions
- OSA, Sleepiness
- Keywords
- OSA, CPAP, sleepiness, donepezil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- 6 Jul 2018 (estimated)
- Primary completion
- 4 Nov 2018 (estimated)
- Study completion
- 2 Mar 2019 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, parallel groups, 30-day trial
| Arm | Type | Receives |
|---|---|---|
| donepezil treatment | Active comparator | Drug: donepezil treatmentdonepezil with 10 mg will be administered for 30 days. |
| placebo treatment | Placebo comparator | Drug: donepezil treatmentplacebo with 10 mg placebo will be administered for 30 days. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Neurological or psychiatric diseases;
- Chronic use of psychoactive drugs, other sleep disorders than OSA, visual defficiency, illiteracy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donepezil treatment30-day donepezil treatment | Drug | donepezil treatment, placebo treatment |
Primary outcome
objective excessive daytime sleepiness
Time frame: 40 days
Maintenance Wakefulness Test
subjective excessive daytime sleepiness
Time frame: 40 days
Epworth Sleepiness Scale
1 secondary outcome
cognitive improvement (executive functions)
Time frame: 40 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing donepezil treatment in people with OSA and Sleepiness, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ksdy Maiara Werli, Psy (+55-11-958491512, ksdymaiara@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective excessive daytime sleepiness (time frame: 40 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.