Effort-based Decision-making and CPAP Adherence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18
AHI±15
Disqualifiers
BMI ≥ 35 Kg/m2
MMSE <24
Complex sleep apnoea
Sleep disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous Positive Airway Pressure (CPAP) treatment
DeviceTreatment of Obstructive sleep apnoea syndrome with CPAP
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: CPAP TreatmentExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Memory
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 treatment2
Executive Function
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 treatment3
Planning
Planning will be assessed with Tower of London
Time frame
Change will be assesd before starting CPAPT and after six months of CPAP treatment4
Response inhibition
Will be assessed with Test Go-nogo
Time frame
Change will be assesd before starting CPAPT and after six months of CPAP treatmentSecondary outcomes
1
Effect of CPAP treatment on memory
Administration of Digit span and California verbal Learning test
Time frame
After six month of CPAP use2
Effect of CPAP treatment on executive function
Administration of Test attentional Performance
Time frame
After six month of CPAP use3
Effect of CPAP on planning
Adimnistration of Tower of London Test
Time frame
After six month of CPAP use4
Effect of CPAP on Response inhibition
administration of go no go Test
Time frame
After six month of CPAP useSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Istituto Universitario di Studi Superiori Pavia
Collaborator
Source ClinicalTrials.gov