Effort-based Decision-making and CPAP Adherence

NCT04557293 | Recruiting

• 1 other identifier: 2425
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Adherence

Keywords

apnoea; effort based decision making; rehabilitation; adherence

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Effect of CPAP treatment on memory

  After six month of CPAP use

• Effect of CPAP treatment on executive function

  After six month of CPAP use

• Effect of CPAP on planning

  After six month of CPAP use

• Effect of CPAP on Response inhibition

  After six month of CPAP use

• Effect of CPAP on effort decision making

  After six month of CPAP use

Study Arms (2)

CPAP Treatment

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Continuous Positive Airway Pressure (CPAP) treatment DEVICE

Treatment of Obstructive sleep apnoea syndrome with CPAP

CPAP Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• AHI±15

You may not qualify if:

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

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Istituto Universitario di Studi Superiori Pavia: collaborator

Study Sites (1)

ICS Maugeri Pavia

Pavia, 27100, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 30736887 BACKGROUND

• 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.

  PMID: 21037021 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea

Interventions

Continuous Positive Airway Pressure; Therapeutics

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Nicola Canessa, PhD

  IRCCS Istituti Clinici Scientifici Maugeri - Scuola superiore IUSS Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Canessa, PhD

CONTACT

+39 0382 375845; nicola.canessa@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 21, 2020
• Study Start: March 10, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

IT (1)