Effort-based Decision-making and CPAP Adherence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Positive Airway Pressure (CPAP) treatment.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea, Adherence. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effort-based Decision-making as a Possible Predictor of Poor Adherence to CPAP Treatment in Obstructive Sleep Apnea
Overview
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.
Interventions
- Device Continuous Positive Airway Pressure (CPAP) treatment
Treatment of Obstructive sleep apnoea syndrome with CPAP
Primary outcome measures
- Memory [Time frame: Change will be assesd before starting CPAP and after six months of CPAP treatment]
- Executive Function [Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment]
- Planning [Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment]
- Response inhibition [Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment]
- Efforth decision making [Time frame: Change will be assesd before starting CPAPT and after six months of CPAP treatment]
Secondary outcome measures (5)
- Effect of CPAP treatment on memory [Time frame: After six month of CPAP use]
- Effect of CPAP treatment on executive function [Time frame: After six month of CPAP use]
- Effect of CPAP on planning [Time frame: After six month of CPAP use]
- Effect of CPAP on Response inhibition [Time frame: After six month of CPAP use]
- Effect of CPAP on effort decision making [Time frame: After six month 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- ICS Maugeri Pavia — Pavia
Publications
- 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. PMID 30736887
- 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. PMID 21037021
Identifiers
NCT: NCT04557293 · 2425