Effort-based Decision-making and CPAPadherence

Not Applicable

Recruiting

• Conditions: Adherence; Obstructive Sleep Apnea
• Interventions: Device: Continuous Positive Airway Pressure (CPAP) treatment

• Registration Number: NCT04557293
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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.

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Study Start: 2021-03-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age ≥ 18
• AHI±15

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP Treatment	Continuous Positive Airway Pressure (CPAP) treatment	Patients with OSA will undergo cognitive assessment before starting CPAP treatment and after six months of CPAP use.

Primary Outcome Measures

Name	Time	Method
Response inhibition	Change will be assesd before starting CPAPT and after six months of CPAP treatment	Will be assessed with Test Go-nogo
Efforth decision making	Change will be assesd before starting CPAPT and after six months of CPAP treatment	Will be assesses with Rapid Serial Visual Presentation (RSVP)
Memory	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	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	Change will be assesd before starting CPAPT and after six months of CPAP treatment	Planning will be assessed with Tower of London

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ICS Maugeri Pavia; 🇮🇹 Pavia, Italy