An interventional study of Continuous Positive Airway Pressure (CPAP) treatment in Obstructive Sleep Apnea and Adherence, sponsored by Istituti Clinici Scientifici Maugeri SpA. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Istituti Clinici Scientifici Maugeri SpA · Not applicable, Interventional, and Other
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.
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 64 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Istituti Clinici Scientifici Maugeri SpA is the lead sponsor of 126 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with OSA will undergo cognitive assessment before starting CPAP treatment and after six months of CPAP use.
Device: Continuous Positive Airway Pressure (CPAP) treatment
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.
Treatment of Obstructive sleep apnoea syndrome with CPAP
Memory
Short and Long-term memory will be assessed with Digit span and California verbal learning test
Time frame: 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)
Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Planning
Planning will be assessed with Tower of London
Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Response inhibition
Will be assessed with Test Go-nogo
Time frame: 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)
Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Effect of CPAP treatment on memory
Administration of Digit span and California verbal Learning test
Time frame: After six month of CPAP use
Effect of CPAP treatment on executive function
Administration of Test attentional Performance
Time frame: After six month of CPAP use
Effect of CPAP on planning
Adimnistration of Tower of London Test
Time frame: After six month of CPAP use
Effect of CPAP on Response inhibition
administration of go no go Test
Time frame: After six month of CPAP use
Effect of CPAP on effort decision making
Administration of Rapid Serial Visual Presentation (RSVP) test
Time frame: After six month of CPAP use
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