Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
In the near future more than 20% of the European population will be over 65 years old and the prevalence of obstructive sleep apnea (OSA) in this aged population is known to be higher than 50%. OSA is a risk factor for cognitive dysfunction in middle-aged subjects, but the relationship between cognitive impairment and sleep breathing disorders (SBD) in the elderly has scarcely been observed.
The aim of this study is to investigate cognitive performance in elderly OSA patients, the corresponding brain morphology changes and biological markers and their reversibility with continuous positive airway pressure (CPAP) treatment.
研究概览
详细说明
Patients: We will include consecutive patients with a diagnosis of severe OSA (AHI> 30) without significant comorbidities or excessive daytime sleepiness (Epworth ≤ 12). Patients will be randomized to CPAP treatment or conservative treatment.
Methodology: We will assess at baseline and after 3 months of treatment:
- Neuroimaging by MRI
- Neurocognitive function with an extensive neuropsychological battery assessing principally memory, attention and executive functions (Trail-making test A and B, Rey Auditory Verbal Learning Test, Digit span, Digit symbol),
- Biological markers of inflammation and endothelial dysfunction.
Patients included in the study will be monitored and followed for three months. They will be examined at the time of inclusion, after two and six weeks and at the end (12 weeks) for clinical monitoring and the evaluation of adaptation to treatment and compliance.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Catalonia
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Barcelona、Catalonia、西班牙、08036
- Hospital Clinic Barcelona
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women ≥ 65 years old.
- Patients diagnosed with OSA with an apnea-hypopnea index per hour >30.
- Patients with an Epworth Sleep Scale score ≤ 12 (without excessive daytime sleepiness).
- Signed written informed consent.
Exclusion Criteria:
- Patients with severe chronic diseases: cardiovascular or pulmonary, neurological (stroke, epilepsy, head injury...) or psychiatric.
- Any current significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol or may, in the opinion of the investigator, compromise the conclusions.
- Mini Mental State Exam (MMSE) <24.
- Any MRI exclusions - presence of aneurysm clips, pacemakers, mechanic heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body.
- Previous CPAP treatment.
- Psycho-physical inability to complete questionnaires. Inadequate visual and auditory acuity will be excluded.
- Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivation, REM behavior disorder and restless leg syndrome.
- Patients with > 50% of central apneas or the presence of Cheyne-Stokes Respiration.
- History of alcohol abuse or dependence.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：CPAP
Patients with CPAP treatment. Titration will be performed by polysomnography or automatic CPAP to determine the optimal treatment pressure. This group will also be instructed in hygienic-dietary measures and sleep hygiene counselling. |
CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling
sleep higiene and dietary counseling
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有源比较器：Standard care for OSA
Sleep hygiene ( regular sleep schedule, avoid sedative drugs, alcohol and tobacco, physical exercise) and dietary counselling
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sleep higiene and dietary counseling
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Structural and functional brain changes
大体时间：at baseline and after 3 months of treatment
|
at baseline and after 3 months of treatment
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Assessment of the changing of the neuropsychological tests.
大体时间：at baseline and after 3 months of treatment
|
at baseline and after 3 months of treatment
|
|
OSA symptoms (daytime sleepiness and everyday function) and quality of life
大体时间：at baseline and after 3 months of treatment
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at baseline and after 3 months of treatment
|
合作者和调查者
调查人员
- 首席研究员：Josep M Montserrat, MD、Spanish Research Center for Respiratory Diseases
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.