Effort-based Decision-making and CPAPadherence
Primary Purpose
Obstructive Sleep Apnea, Adherence
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP) treatment
Sponsored by
About this trial
This is an interventional other trial for Obstructive Sleep Apnea focused on measuring apnoea, effort based decision making, rehabilitation, adherence
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18
- AHI±15
Exclusion Criteria:
- BMI ≥ 35 Kg/m2
- MMSE <24
- Complex sleep apnoea
- Sleep disorder
- Psychiatric disorder
Sites / Locations
- ICS Maugeri PaviaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CPAP Treatment
Control Group
Arm Description
Patients with OSA will undergo cognitive assessment before starting CPAP treatment and after six months of CPAP use.
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.
Outcomes
Primary Outcome Measures
Memory
Short and Long-term memory will be assessed with Digit span and California verbal learning test
Executive Function
attentional and executive functioning will be assessed with Test of Attentional Performance (TAP)
Planning
Planning will be assessed with Tower of London
Response inhibition
Will be assessed with Test Go-nogo
Efforth decision making
Will be assesses with Rapid Serial Visual Presentation (RSVP)
Secondary Outcome Measures
Effect of CPAP treatment on memory
Administration of Digit span and California verbal Learning test
Effect of CPAP treatment on executive function
Administration of Test attentional Performance
Effect of CPAP on planning
Adimnistration of Tower of London Test
Effect of CPAP on Response inhibition
administration of go no go Test
Effect of CPAP on effort decision making
Administration of Rapid Serial Visual Presentation (RSVP) test
Full Information
NCT ID
NCT04557293
First Posted
August 31, 2020
Last Updated
September 18, 2023
Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Istituto Universitario di Studi Superiori Pavia
1. Study Identification
Unique Protocol Identification Number
NCT04557293
Brief Title
Effort-based Decision-making and CPAPadherence
Official Title
Effort-based Decision-making as a Possible Predictor of Poor Adherence to CPAP Treatment in Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborators
Istituto Universitario di Studi Superiori Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Adherence
Keywords
apnoea, effort based decision making, rehabilitation, adherence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP Treatment
Arm Type
Experimental
Arm Description
Patients with OSA will undergo cognitive assessment before starting CPAP treatment and after six months of CPAP use.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP) treatment
Intervention Description
Treatment of Obstructive sleep apnoea syndrome with CPAP
Primary Outcome Measure Information:
Title
Memory
Description
Short and Long-term memory will be assessed with Digit span and California verbal learning test
Time Frame
Change will be assesd before starting CPAP and after six months of CPAP treatment
Title
Executive Function
Description
attentional and executive functioning will be assessed with Test of Attentional Performance (TAP)
Time Frame
Change will be assesd before starting CPAPT and after six months of CPAP treatment
Title
Planning
Description
Planning will be assessed with Tower of London
Time Frame
Change will be assesd before starting CPAPT and after six months of CPAP treatment
Title
Response inhibition
Description
Will be assessed with Test Go-nogo
Time Frame
Change will be assesd before starting CPAPT and after six months of CPAP treatment
Title
Efforth decision making
Description
Will be assesses with Rapid Serial Visual Presentation (RSVP)
Time Frame
Change will be assesd before starting CPAPT and after six months of CPAP treatment
Secondary Outcome Measure Information:
Title
Effect of CPAP treatment on memory
Description
Administration of Digit span and California verbal Learning test
Time Frame
After six month of CPAP use
Title
Effect of CPAP treatment on executive function
Description
Administration of Test attentional Performance
Time Frame
After six month of CPAP use
Title
Effect of CPAP on planning
Description
Adimnistration of Tower of London Test
Time Frame
After six month of CPAP use
Title
Effect of CPAP on Response inhibition
Description
administration of go no go Test
Time Frame
After six month of CPAP use
Title
Effect of CPAP on effort decision making
Description
Administration of Rapid Serial Visual Presentation (RSVP) test
Time Frame
After six month of CPAP use
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18
AHI±15
Exclusion Criteria:
BMI ≥ 35 Kg/m2
MMSE <24
Complex sleep apnoea
Sleep disorder
Psychiatric disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Canessa, PhD
Phone
+39 0382 375845
Email
nicola.canessa@icsmaugeri.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Canessa, PhD
Organizational Affiliation
IRCCS Istituti Clinici Scientifici Maugeri - Scuola superiore IUSS Pavia
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICS Maugeri Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
30736887
Citation
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.
Results Reference
background
PubMed Identifier
21037021
Citation
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.
Results Reference
background
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Effort-based Decision-making and CPAPadherence
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