NCT04775966已完成不适用
CPAP Observance During the COVID-19 (SARS-CoV-2) Pandemic
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8,477
- 试验地点
- 1
- 主要终点
- Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)
研究概览
简要总结
The hypothesis of this work is that the COVID 19 pandemic and the associated lockdowns are likely to modify the adherence to positive airway pressure (PAP) treatments among patients with sleep apnea. Identifying these patients and identifying adherence "trajectories" over time would help mobilize human and telemedicine resources on the patients most in need.
详细描述
The primary objective of this study is to compare PAP adherence during lockdowns in 2020 with the corresponding weeks during 2019.
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
- 否
入选标准
- •patient treated/monitored by the Adene group
- •treated for sleep apnea syndrome (i.e., an initial apnoea hypopnea index (iAHI) ≥ 30/h or iAHI ≥ 15/h (and more than 10/h respiratory-effort-related arousal or cardio-metabolic/respiratory comorbidities) associated with symptoms from among sleepiness, tiredness, snoring, headaches, hypertension, reduced vigilance, libido disorders, nocturia, choking or suffocation during sleep, daytime tiredness)
- •Positive airway pressure (PAP)-treated for at least 4 months before January 1, 2019
- •continuous PAP during 2019
- •continuous PAP during 2020
- •acceptance of PAP telemonitoring with consent given for data collection and data anonymization
排除标准
- •less than 360 daily PAP tele-monitored data per year for 2019
- •less than 360 daily PAP tele-monitored data per year for 2020
结局指标
主要结局
Change in positive airway pressure(PAP)-adherence during the first lockdown versus corresponding 2019 weeks (h/days)
时间窗: 2020 versus 2019
次要结局
- Change in the percentage of adherent patients (adherence > 4h/day/week) during the first lockdown versus corresponding 2019 weeks (h/days)(2020 versus 2019)
- Change in positive airway pressure(PAP)-adherence during the second lockdown versus corresponding 2019 weeks (h/days)(2020 versus 2019)
- Change in PAP-adherence 2020 versus 2019 (h/days/weeks)(2020 versus 2019)
- Change in patient adherence 2020 versus 2019 (%).(2020 versus 2019)
- Change in the percentage of adherent patients (adherence > 4h/day/week) during the second lockdown versus corresponding 2019 weeks (h/days)(2020 versus 2019)
研究者
研究点 (1)
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