Clinical trial NCT04557293: 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
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Adherence
Keywords: apnoea
effort based decision making
rehabilitation
adherence
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: Istituto Universitario di Studi Superiori Pavia
First posted: 2020-09-21
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* AHI±15

Exclusion Criteria:

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

Primary outcomes:
measure: Memory
timeFrame: Change will be assesd before starting CPAP and after six months of CPAP treatment
measure: Executive Function
timeFrame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
measure: Planning
timeFrame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
measure: Response inhibition
timeFrame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
measure: Efforth decision making
timeFrame: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Secondary outcomes:
measure: Effect of CPAP treatment on memory
timeFrame: After six month of CPAP use
measure: Effect of CPAP treatment on executive function
timeFrame: After six month of CPAP use
measure: Effect of CPAP on planning
timeFrame: After six month of CPAP use
measure: Effect of CPAP on Response inhibition
timeFrame: After six month of CPAP use
measure: Effect of CPAP on effort decision making
timeFrame: After six month of CPAP use
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: ICS Maugeri Pavia
Study officials:
affiliation: IRCCS Istituti Clinici Scientifici Maugeri - Scuola superiore IUSS Pavia
name: Nicola Canessa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.