Effort-based Decision-making and CPAPadherence

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obstructive Sleep Apnea, Adherence

Intervention / Treatment
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* Device: Continuous Positive Airway Pressure (CPAP) treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 AHI±15 Exclusion Criteria: BMI ≥ 35 Kg/m2 MMSE <24 Complex sleep apnoea Sleep disorder Psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP Treatment<br>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<br>* Treatment of Obstructive sleep apnoea syndrome with CPAP<br>|
| No Intervention: Control Group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory | Short and Long-term memory will be assessed with Digit span and California verbal learning test | 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) | Change will be assesd before starting CPAPT and after six months of CPAP treatment | 
| Planning | Planning will be assessed with Tower of London | Change will be assesd before starting CPAPT and after six months of CPAP treatment | 
| Response inhibition | Will be assessed with Test Go-nogo | 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) | Change will be assesd before starting CPAPT and after six months of CPAP treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of CPAP treatment on memory | Administration of Digit span and California verbal Learning test | After six month of CPAP use | 
| Effect of CPAP treatment on executive function | Administration of Test attentional Performance | After six month of CPAP use | 
| Effect of CPAP on planning | Adimnistration of Tower of London Test | After six month of CPAP use | 
| Effect of CPAP on Response inhibition | administration of go no go Test | After six month of CPAP use | 
| Effect of CPAP on effort decision making | Administration of Rapid Serial Visual Presentation (RSVP) test | After six month of CPAP use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apnoea, effort based decision making, rehabilitation, adherence