Effort-based Decision-making and CPAP Adherence

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: Adherence; Obstructive Sleep Apnea

Treatments: Device: Continuous Positive Airway Pressure (CPAP) treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04557293

2425

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• AHI±15

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

CPAP Treatment

Experimental group

Description:

Patients with OSA will undergo cognitive assessment before starting CPAP treatment and after six months of CPAP use.

Treatment:

Device: Continuous Positive Airway Pressure (CPAP) treatment

Control Group

No Intervention group

Description:

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.