Obstructive Sleep Apneas in Elderly:Neuroimaging Changes and Neurocognitive Function Before and After Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Structural and functional brain changes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 65 years old.
- •Patients diagnosed with OSA with an apnea-hypopnea index per hour >
- •Patients with an Epworth Sleep Scale score ≤ 12 (without excessive daytime sleepiness).
- •Signed written informed consent.
排除标准
- •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) <
- •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.
研究组 & 干预措施
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.
干预措施: CPAP (Device)
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.
干预措施: Standard care for OSA (Other)
Standard care for OSA
Sleep hygiene ( regular sleep schedule, avoid sedative drugs, alcohol and tobacco, physical exercise) and dietary counselling
干预措施: Standard care for OSA (Other)
结局指标
主要结局
Structural and functional brain changes
时间窗: at baseline and after 3 months of treatment
次要结局
- Assessment of the changing of the neuropsychological tests.(at baseline and after 3 months of treatment)
- OSA symptoms (daytime sleepiness and everyday function) and quality of life(at baseline and after 3 months of treatment)
研究者
Jose M. Montserrat
MD
Hospital Clinic of Barcelona