Effort-based Decision-making and CPAPadherence

September 18, 2023 updated by: Istituti Clinici Scientifici Maugeri SpA

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Recruiting
        • ICS Maugeri Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18
  • AHI±15

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP Treatment
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
Treatment of Obstructive sleep apnoea syndrome with CPAP
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change will be assesd before starting CPAP and after six months of CPAP treatment
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)
Change will be assesd before starting CPAPT and after six months of CPAP treatment
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
Change will be assesd before starting CPAPT and after six months of CPAP treatment
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
Change will be assesd before starting CPAPT and after six months of CPAP treatment
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)
Change will be assesd before starting CPAPT and after six months of CPAP treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

Istituto Universitario di Studi Superiori Pavia

Investigators

  • Principal Investigator: Nicola Canessa, PhD, IRCCS Istituti Clinici Scientifici Maugeri - Scuola superiore IUSS Pavia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2425

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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