Registro español de Pacientes Con Apnea Del sueño y Somnolencia Diurna
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Primary Outcome
研究概览
简要总结
Multicenter, observational and prospective study, in which patients referred to the sleep unit with suspected apnea will be recruited obstructive sleep. 1000 patients referred to the sleep unit will be recruited with suspected obstructive sleep apnea. The recruited patients will undergo a sleep study for the diagnosis of OSA, ambulatory monitoring of blood pressure (ABP) of 24 hours, clinical variables will be obtained, questionnaires of quality of life, Epworth test for the evaluation of daytime sleepiness, variables biochemistry and obtaining biological samples. OSA patients will be managed following the usual practice. In those patients for whom the treatment with CPAP an evaluation of adherence to treatment will be carried out.
OSA patients will be evaluated at baseline, 6, 12, and 24 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who come to the sleep consultation for sleep study results for suspected OSA.
- •Patients older than 18 years.
- •Signature of the informed consent.
排除标准
- •Psycho-physical inability to complete questionnaires.
- •Presence of any previously diagnosed sleep disorder: narcolepsy, insomnia, sleep deprivation (less than 6h/day), regular use of medications hypnotics or sedatives (may be included if you only use a short-acting benzodiazepine or melatonin) and restless legs syndrome.
- •Patients with > 50% central apnea or presence of Cheyne-Stokes respiration (CSRsp).
- •A medical history that may interfere with the objectives of the study or that in the judgment of the investigator compromises the conclusions.
- •Any medical, social or geographical factor that may endanger the patient compliance. (eg, alcohol consumption (more than 80 g/day in men and more than 60 gr / day in women), absence of stable habitual residence, disorientation or non-compliance history).
- •Any process, cardiovascular or not, that limits life expectancy to less than one year.
研究组 & 干预措施
NO OSA
Control group
干预措施: Diagnosis (Diagnostic Test)
OSA WHITH CPAP
干预措施: Diagnosis (Diagnostic Test)
OSA WHITHOUT CPAP
干预措施: Diagnosis (Diagnostic Test)
结局指标
主要结局
Primary Outcome
时间窗: 6 months
Data analysis of the AHI in the respiratory polygraphy
次要结局
未报告次要终点