Effort-based Decision-making and CPAP Adherence

NCT ID: NCT04557293

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2026-04-30

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.

Conditions

Obstructive Sleep Apnea; Adherence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CPAP Treatment

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

Group Type: EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP) treatment

Intervention Type: DEVICE

Treatment of Obstructive sleep apnoea syndrome with CPAP

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Continuous Positive Airway Pressure (CPAP) treatment

Treatment of Obstructive sleep apnoea syndrome with CPAP

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18
• AHI±15

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Universitario di Studi Superiori Pavia

OTHER

Sponsor Role: collaborator

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicola Canessa, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Istituti Clinici Scientifici Maugeri - Scuola superiore IUSS Pavia

Locations

ICS Maugeri Pavia

Pavia, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Nicola Canessa, PhD

Role: CONTACT

nicola.canessa@icsmaugeri.it

+39 0382 375845

References

Patil SP, Ayappa IA, Caples SM, Kimoff RJ, Patel SR, Harrod CG. Treatment of Adult Obstructive Sleep Apnea with Positive Airway Pressure: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2019 Feb 15;15(2):335-343. doi: 10.5664/jcsm.7640.

Reference Type: BACKGROUND

PMID: 30736887 (View on PubMed)

Canessa N, Castronovo V, Cappa SF, Aloia MS, Marelli S, Falini A, Alemanno F, Ferini-Strambi L. Obstructive sleep apnea: brain structural changes and neurocognitive function before and after treatment. Am J Respir Crit Care Med. 2011 May 15;183(10):1419-26. doi: 10.1164/rccm.201005-0693OC. Epub 2010 Oct 29.

Reference Type: BACKGROUND

PMID: 21037021 (View on PubMed)

Other Identifiers

2425

Identifier Type: -

Identifier Source: org_study_id