Obstructive Sleep ApneaNCT04557293
Effort-based Decision-making and CPAP Adherence
A study testing Continuous Positive Airway Pressure (CPAP) treatment in people with Obstructive Sleep Apnea and Adherence, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial summary
Obstructive sleep apnoea is the most common sleep disorder in general population, and is often associated with cognitive deficit, mood disorders, hypertension, diabetes mellitus, excessive daytime somnolence, nicturia and an increased cardiovascular and metabolic risk. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Adherence
- What is being tested?
- Continuous Positive Airway Pressure (CPAP) treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 10 Mar 2021to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- AHI±15
Who cannot join
- BMI ≥ 35 Kg/m2
- MMSE <24
- Complex sleep apnoea
- Sleep disorder
- Psychiatric disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effort-based Decision-making as a Possible Predictor of Poor Adherence to CPAP Treatment in Obstructive Sleep Apnea
Obstructive sleep apnoea is the most common sleep disorder in general population, and is often associated with cognitive deficit, mood disorders, hypertension, diabetes mellitus, excessive daytime somnolence, nicturia and an increased cardiovascular and metabolic risk. The gold standard of treatment is Continuous Positive Airway Pressure (CPAP), but the adherence is often poor. The aim of our study is to investigate the effort based-decision making in patients with OSA, pre and post CPAP treatment, as a possible cause of poor adherence.
Read the detailed description
Obstructive sleep apnea is a very common disease in general population (24% males; 9% females), characterized by frequent partial or total upper-airway collapse, intermittent hypoxia, arousal from sleep, change in blood pressure, excessive daytime sleepiness, cardiovascular and metabolic diseases, psychological and cognitive consequences. The gold standard treatment is Continuous Positive Airway Pressure (CPAP), but the adherence is often poor. Poor therapy adherence might be partially explained by executive deficits, decreasing the ability to plan and pursue longsighted behaviors entailing immediate costs/efforts. We investigate the cognitive function, in particular effort based-decision making and the relationship with excessive daytime somnolence and other cognitive function in a group of OSA patients and in control group. We assess cognitive function in OSA patients at the diagnosis moment and after six months of CPAP use.
- Conditions
- Obstructive Sleep Apnea, Adherence
- Being tested
- Continuous Positive Airway Pressure (CPAP) treatment
- Keywords
- apnoea, effort based decision making, rehabilitation, adherence
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP) treatmentDevice
Treatment of Obstructive sleep apnoea syndrome with CPAP
| Study group | Role | What they receive |
|---|---|---|
| CPAP Treatment | Experimental | Patients with OSA will undergo cognitive assessment before starting CPAP treatment and after six months of CPAP use. Receives: Device: Continuous Positive Airway Pressure (CPAP) treatment |
| Control Group | No intervention | We will enrol a control group of subjects without sleep disorders and comparable to OSA patients for age and schooling. Control group will undergo cognitive assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory
Short and Long-term memory will be assessed with Digit span and California verbal learning test
Measured: Change will be assesd before starting CPAP and after six months of CPAP treatment
Executive Function
attentional and executive functioning will be assessed with Test of Attentional Performance (TAP)
Measured: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Planning
Planning will be assessed with Tower of London
Measured: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Response inhibition
Will be assessed with Test Go-nogo
Measured: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Efforth decision making
Will be assesses with Rapid Serial Visual Presentation (RSVP)
Measured: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Secondary outcomes (5)
Effect of CPAP treatment on memory
Administration of Digit span and California verbal Learning test
Measured: After six month of CPAP use
Effect of CPAP treatment on executive function
Administration of Test attentional Performance
Measured: After six month of CPAP use
Effect of CPAP on planning
Adimnistration of Tower of London Test
Measured: After six month of CPAP use
Effect of CPAP on Response inhibition
administration of go no go Test
Measured: After six month of CPAP use
Effect of CPAP on effort decision making
Administration of Rapid Serial Visual Presentation (RSVP) test
Measured: After six month of CPAP use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start10 Mar 2021
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Universitario di Studi Superiori Pavia
- Responsible party
- Sponsor
- Investigators
- Nicola Canessa, PhD, Principal investigator, IRCCS Istituti Clinici Scientifici Maugeri - Scuola superiore IUSS Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557293
- Sponsor's protocol ID
- 2425
- Status last verified
- Nov 2025
- First submitted
- 31 Aug 2020
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2019 Feb 15;15(2):335-343. doi: 10.5664/jcsm.7640.
PubMed 30736887Canessa N, Castronovo V, Cappa SF, Aloia MS, Marelli S, Falini A, Alemanno F, Ferini-Strambi L. Obstructive sleep apnea: brain structural changes and neurocognitive function before and after treatment. Am J Respir Crit Care Med. 2011 May 15;183(10):1419-26. doi: 10.1164/rccm.201005-0693OC. Epub 2010 Oct 29.
PubMed 21037021
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effort-based Decision-making as a Possible Predictor of Poor Adherence to CPAP Treatment in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04557293
- Acronym / sponsor ID
- 2425
- Conditions
- Obstructive Sleep Apnea, Adherence
- Keywords
- apnoea, effort based decision making, rehabilitation, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Istituto Universitario di Studi Superiori Pavia
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 21 Sep 2020 (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.
Obstructive sleep apnoea is the most common sleep disorder in general population, and is often associated with cognitive deficit, mood disorders, hypertension, diabetes mellitus, excessive daytime somnolence, nicturia and an increased cardiovascular and metabolic risk. The gold standard of treatment is Continuous Positive Airway Pressure (CPAP), but the adherence is often poor. The aim of our study is to investigate the effort based-decision making in patients with OSA, pre and post CPAP treatment, as a possible cause of poor adherence.
Detailed description
Obstructive sleep apnea is a very common disease in general population (24% males; 9% females), characterized by frequent partial or total upper-airway collapse, intermittent hypoxia, arousal from sleep, change in blood pressure, excessive daytime sleepiness, cardiovascular and metabolic diseases, psychological and cognitive consequences. The gold standard treatment is Continuous Positive Airway Pressure (CPAP), but the adherence is often poor. Poor therapy adherence might be partially explained by executive deficits, decreasing the ability to plan and pursue longsighted behaviors entailing immediate costs/efforts. We investigate the cognitive function, in particular effort based-decision making and the relationship with excessive daytime somnolence and other cognitive function in a group of OSA patients and in control group. We assess cognitive function in OSA patients at the diagnosis moment and after six months of CPAP use.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP Treatment | Experimental | Device: Continuous Positive Airway Pressure (CPAP) treatmentPatients with OSA will undergo cognitive assessment before starting CPAP treatment and after six months of CPAP use. |
| Control Group | No intervention | –We will enrol a control group of subjects without sleep disorders and comparable to OSA patients for age and schooling. Control group will undergo cognitive assessment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- AHI±15
Key exclusion criteria (5 listed)
- BMI ≥ 35 Kg/m2
- MMSE <24
- Complex sleep apnoea
- Sleep disorder
- Psychiatric disorder
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 |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP) treatmentTreatment of Obstructive sleep apnoea syndrome with CPAP | Device | CPAP Treatment |
Primary outcome
Memory
Time frame: Change will be assesd before starting CPAP and after six months of CPAP treatment
Short and Long-term memory will be assessed with Digit span and California verbal learning test
Executive Function
Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
attentional and executive functioning will be assessed with Test of Attentional Performance (TAP)
Planning
Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Planning will be assessed with Tower of London
Response inhibition
Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Will be assessed with Test Go-nogo
Efforth decision making
Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Will be assesses with Rapid Serial Visual Presentation (RSVP)
5 secondary outcomes
Effect of CPAP treatment on memory
Time frame: After six month of CPAP use
Effect of CPAP treatment on executive function
Time frame: After six month of CPAP use
Effect of CPAP on planning
Time frame: After six month of CPAP use
Effect of CPAP on Response inhibition
Time frame: After six month of CPAP use
Effect of CPAP on effort decision making
Time frame: After six month of CPAP use
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 30736887Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2019 Feb 15;15(2):335-343. doi: 10.5664/jcsm.7640.
- Background: PubMed 21037021Canessa N, Castronovo V, Cappa SF, Aloia MS, Marelli S, Falini A, Alemanno F, Ferini-Strambi L. Obstructive sleep apnea: brain structural changes and neurocognitive function before and after treatment. Am J Respir Crit Care Med. 2011 May 15;183(10):1419-26. doi: 10.1164/rccm.201005-0693OC. Epub 2010 Oct 29.
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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.
Nicola Canessa, PhD principal investigator
IRCCS Istituti Clinici Scientifici Maugeri - Scuola superiore IUSS Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) treatment in people with Obstructive Sleep Apnea and Adherence, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 18 Nov 2025. 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 Italy. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Canessa, PhD (+39 0382 375845, nicola.canessa@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory (time frame: Change will be assesd before starting CPAP and after six months of CPAP treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04557293, which also lists 2 linked publications.
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 18 Nov 2025.