Effort-based Decision-making as a Possible Predictor of Poor Adherence to CPAP Treatment in Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Response inhibition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •BMI ≥ 35 Kg/m2
- •MMSE <24
- •Complex sleep apnoea
- •Sleep disorder
- •Psychiatric disorder
结局指标
主要结局
Response inhibition
时间窗: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Will be assessed with Test Go-nogo
Efforth decision making
时间窗: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Will be assesses with Rapid Serial Visual Presentation (RSVP)
Memory
时间窗: Change will be assesd before starting CPAP and after six months of CPAP treatment
Short and Long-term memory will be assessed with Digit span and California verbal learning test
Executive Function
时间窗: Change will be assesd before starting CPAPT and after six months of CPAP treatment
attentional and executive functioning will be assessed with Test of Attentional Performance (TAP)
Planning
时间窗: Change will be assesd before starting CPAPT and after six months of CPAP treatment
Planning will be assessed with Tower of London
次要结局
- Effect of CPAP treatment on executive function(After six month of CPAP use)
- Effect of CPAP on planning(After six month of CPAP use)
- Effect of CPAP on Response inhibition(After six month of CPAP use)
- Effect of CPAP on effort decision making(After six month of CPAP use)
- Effect of CPAP treatment on memory(After six month of CPAP use)