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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04557293
Other study ID # 2425
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2021
Est. completion date December 31, 2024

Study information

Verified date September 2023
Source Istituti Clinici Scientifici Maugeri SpA
Contact Nicola Canessa, PhD
Phone +39 0382 375845
Email nicola.canessa@icsmaugeri.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date December 31, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age = 18 - AHIĀ±15 Exclusion Criteria: - BMI = 35 Kg/m2 - MMSE <24 - Complex sleep apnoea - Sleep disorder - Psychiatric disorder

Study Design


Intervention

Device:
Continuous Positive Airway Pressure (CPAP) treatment
Treatment of Obstructive sleep apnoea syndrome with CPAP

Locations

Country Name City State
Italy ICS Maugeri Pavia Pavia

Sponsors (2)

Lead Sponsor Collaborator
Istituti Clinici Scientifici Maugeri SpA Istituto Universitario di Studi Superiori Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Planning Planning will be assessed with Tower of London Change will be assesd before starting CPAPT and after six months of CPAP treatment
Primary Response inhibition Will be assessed with Test Go-nogo Change will be assesd before starting CPAPT and after six months of CPAP treatment
Primary 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 Effect of CPAP treatment on memory Administration of Digit span and California verbal Learning test After six month of CPAP use
Secondary Effect of CPAP treatment on executive function Administration of Test attentional Performance After six month of CPAP use
Secondary Effect of CPAP on planning Adimnistration of Tower of London Test After six month of CPAP use
Secondary Effect of CPAP on Response inhibition administration of go no go Test After six month of CPAP use
Secondary Effect of CPAP on effort decision making Administration of Rapid Serial Visual Presentation (RSVP) test After six month of CPAP use
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