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NCT Number: NCT04557293

Effort-based Decision-making and CPAP Adherence

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ICS Maugeri Pavia

Pavia, 27100, Italy

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • AHI±15

Exclusion criteria

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP) Treatment

Device

Treatment of Obstructive sleep apnoea syndrome with CPAP

Primary outcomes

  1. Memory

    Time frame: 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

  2. Executive Function

    Time frame: 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)

  3. Planning

    Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment

    Planning will be assessed with Tower of London

  4. Response inhibition

    Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment

    Will be assessed with Test Go-nogo

  5. Efforth decision making

    Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment

    Will be assesses with Rapid Serial Visual Presentation (RSVP)

Secondary outcomes

  1. Effect of CPAP treatment on memory

    Time frame: After six month of CPAP use

    Administration of Digit span and California verbal Learning test

  2. Effect of CPAP treatment on executive function

    Time frame: After six month of CPAP use

    Administration of Test attentional Performance

  3. Effect of CPAP on planning

    Time frame: After six month of CPAP use

    Adimnistration of Tower of London Test

  4. Effect of CPAP on Response inhibition

    Time frame: After six month of CPAP use

    administration of go no go Test

  5. Effect of CPAP on effort decision making

    Time frame: After six month of CPAP use

    Administration of Rapid Serial Visual Presentation (RSVP) test

Study contacts

Contact information is provided by the study sponsor or research team.

Nicola Canessa, PhD

CONTACT

[email protected]

+39 0382 375845

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

  • Istituto Universitario di Studi Superiori Pavia

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2020
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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