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Effort-based Decision-making and CPAP Adherence

Effort-based Decision-making as a Possible Predictor of Poor Adherence to CPAP Treatment in Obstructive Sleep Apnea

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04557293
Enrollment
64
Registered
2020-09-21
Start date
2021-03-10
Completion date
2026-04-30
Last updated
2025-11-18

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

Conditions

Adherence, Obstructive Sleep Apnea

Keywords

apnoea, effort based decision making, rehabilitation, adherence

Brief 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. 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.

Interventions

Treatment of Obstructive sleep apnoea syndrome with CPAP

Sponsors

Istituto Universitario di Studi Superiori Pavia
CollaboratorOTHER
Istituti Clinici Scientifici Maugeri SpA
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Age ≥ 18 * AHI±15

Exclusion criteria

* BMI ≥ 35 Kg/m2 * MMSE \<24 * Complex sleep apnoea * Sleep disorder * Psychiatric disorder

Design outcomes

Primary

MeasureTime frameDescription
Efforth decision makingChange will be assesd before starting CPAPT and after six months of CPAP treatmentWill be assesses with Rapid Serial Visual Presentation (RSVP)
MemoryChange will be assesd before starting CPAP and after six months of CPAP treatmentShort and Long-term memory will be assessed with Digit span and California verbal learning test
Executive FunctionChange will be assesd before starting CPAPT and after six months of CPAP treatmentattentional and executive functioning will be assessed with Test of Attentional Performance (TAP)
PlanningChange will be assesd before starting CPAPT and after six months of CPAP treatmentPlanning will be assessed with Tower of London
Response inhibitionChange will be assesd before starting CPAPT and after six months of CPAP treatmentWill be assessed with Test Go-nogo

Secondary

MeasureTime frameDescription
Effect of CPAP treatment on memoryAfter six month of CPAP useAdministration of Digit span and California verbal Learning test
Effect of CPAP treatment on executive functionAfter six month of CPAP useAdministration of Test attentional Performance
Effect of CPAP on planningAfter six month of CPAP useAdimnistration of Tower of London Test
Effect of CPAP on Response inhibitionAfter six month of CPAP useadministration of go no go Test
Effect of CPAP on effort decision makingAfter six month of CPAP useAdministration of Rapid Serial Visual Presentation (RSVP) test

Countries

Italy

Contacts

Primary ContactNicola Canessa, PhD
nicola.canessa@icsmaugeri.it+39 0382 375845

Outcome results

None listed

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