跳至主要内容
临床试验/NCT04274400
NCT04274400Unknown不适用

Comorbid Insomnia and Sleep Apnea in Patients Referred to Polysomnography

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 215 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
215
试验地点
1
主要终点
Frequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia

研究概览

简要总结

Insomnia and OSA coexist in clinical populations, but the prevalence of comorbid insomnia among OSA patients in the community and risk factors remain poorly known. Little is known about the impact of sleep apnea and insomnia on the quality of life and quality of sleep compared to the presence of one of the sleep disorders alone. Our hypothesis is that the co-existence of OSA and insomnia is high in our community. We also hypothesized that the co-existence of OSA and insomnia promotes greater impairment of quality of life and quality of sleep when compared to the presence of OSA or insomnia alone.

Patients referred to polysomnography will be submitted to 6 questionnaires to assess daytime sleepiness (EPWORTH), insomnia severity index (ISI), anxiety and depression assessment (Beck's anxiety and depression inventory), quality of life assessment(WHOQOL- BREF) and sleep quality assessment (Pittsburgh questionnaire) and they will also be submitted to a polysomnography type III.

It will be calculated the frequency of insomnia, OSA and the comorbidity between insomnia and OSA in the sample. It will be analysed correlations between the insomnia severity index, apnea and hypopnea index, Epworth sleepiness scale, quality of life scale (WHOQOL-BREF), anxiety and depression scale (Beck's anxiety and depression inventory) and Pittsburgh sleep quality scale. Insomnia severity index scores, Epworth sleepiness scale, quality of life scale (WHOQOL-BREF), anxiety and depression scale (Beck anxiety and depression inventory) and Pittsburgh sleep quality scale will be compared according to the presence and absence of OSA and the presence and absence of insomnia and the presence of the comorbidity insomnia and OSA.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who will participate in the task force for the diagnosis of sleep apnea promoted by the State Department of Health in an agreement signed with the Heart Institute

排除标准

  • individuals under 18 years old

结局指标

主要结局

Frequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia

时间窗: 6 months

Frequency of obstructive sleeep apnea, insomnia and comorbid sleep apnea and insomnia

次要结局

  • Correlations between scales: EPWORTH, ISI, Beck's anxiety and depression inventory, WHOQOL-BREF and Pittsburgh questionnaire(6 months)

研究者

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

Pedro Rodrigues Genta

Associate Professor

University of Sao Paulo General Hospital

研究点 (1)

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