跳至主要内容
临床试验/NCT03079466
NCT03079466Unknown不适用

Effect of CPAP Treatment on the Elderly With Mild to Moderate Sleep Apnea

Hospital Universitario Doctor Peset0 个研究点目标入组 96 人开始时间: 2017年3月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
96
主要终点
Quebec Sleep Questionnaire domains

研究概览

简要总结

Objective: To analyze the impact of CPAP treatment on cognitive, clinical and quality of life domains in patients over 70 years of age with mild-to-moderate OSA

Primary Outcome: Epworth scale and QSQ domains

Secondary Outcomes: Neurocognitive variables and CPAP adherence

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
None

入排标准

年龄范围
70 Years 至 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age equal or greater than 70 years of both sexes
  • Patients with sleep study results with AHI ≥ 15 and < 30

排除标准

  • Alternative diagnoses of other non-respiratory sleep disorders that are also cause of pathological somnolence (eg, sdr restless legs, narcolepsy, etc.)
  • Don't sign informed consent
  • Acute or chronic respiratory insufficiency requiring home oxygen therapy
  • Patients with Obesity Hypoventilation Syndrome
  • Diagnosis of neuro-psychiatric diseases with the exception of anxiety - depression or diagnosis of dementia.
  • Diseases of any origin in the acute phase
  • Heart failure or recent stroke (less than 3 months).
  • Central SAHS (more than 50% of the registry with central apneas or Cheyne-Stokes breathing)
  • Pre-treatment with CPAP
  • Inability to perform the diagnostic study of sleep due to the patient's condition
  • Hipersomniaincapacitante (Epworth≥18) with no known or most likely cause related to SAHS

结局指标

主要结局

Quebec Sleep Questionnaire domains

时间窗: 3 months

Quality of Life measured in sleep apnea patients

Epworth Sleepiness Scale

时间窗: 3 months

Measure of diurnal sleepiness

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Ponce Perez

Doctor

Hospital Universitario Doctor Peset

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