Effort-based Decision-making and CPAPadherence

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04557293
• Other study ID #: 2425
• Status: Recruiting
• Phase: N/A
• 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
• 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

• AHI±15

Exclusion Criteria:

• BMI = 35 Kg/m2

• MMSE <24

• Complex sleep apnoea

• Sleep disorder

• Psychiatric disorder

Related Conditions & MeSH terms

• Adherence
• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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