Sleep Characteristics in Post-Corona Virus Disease 2019 Patients Compared to Healthy Controls - An Observational Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea-Index (AHI)
研究概览
简要总结
After acute infection, patients with coronavirus disease 2019 (COVID-19) often suffer from persisting symptoms for more than 3 months (post COVID-19). Sleep disorders (31%) have already been assessed by questionnaires and interviews in post-COVID-19, but have not yet been proven by polysomnography (PSG), the gold standard for sleep testing. This study aimed to measure sleep characteristics in post-COVID-19 patients.
详细描述
Hypothesis
We hypothesize that post-COVID-19 patients have a significantly higher apnea-hypopnea index (AHI) during sleep compared to healthy controls.
15 post-COVID-19 patients and 15 healthy controls will perform a baseline assessment on day 1 including a 1-minute sit-to-stand test (STST), post-COVID functional scale (PCFS), Ordinal Scale for Clinical Improvement (OSCI), history of COVID-19, social anamnesis, Pittsburgh Sleep Questionnaire and subjective limitations of sleep.
On day 4, after an initialization phase for WHOOP strap (a digital fitness and health coach), all patients performed a single night sleep assessment in a sleep lab via Polysomnography and WHOOP.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-COVID-19 Group:
- •Patients after SARS-CoV-2 infection with signs of Post-COVID-19
- •≥18 years
- •written informed consent
- •Healthy controls:
- •No history of SARS-CoV-2 infection
- •≥18 years
- •written informed consent
排除标准
- •Post-COVID-19 Group:
- •Diagnosis of a breathing-related sleep disorder before SARS-CoV-2 infection
- •BMI >25kg/m2
- •Healthy controls:
- •Diagnosis of a breathing-related sleep disorder
- •BMI >25kg/m2
结局指标
主要结局
Apnea-Hypopnea-Index (AHI)
时间窗: One single night on study day 4
Number of apnea or hypopnea Events per hour of sleep
次要结局
- Mixed apnea(One single night on study day 4)
- Light sleep phase(One single night on study day 4)
- Periodic leg movement Index(One single night on study day 4)
- Obstructive apnea(One single night on study day 4)
- Central apnea(One single night on study day 4)
- Rapid Eye Movement (REM) sleep phase(One single night on study day 4)
- Deep sleep phase(One single night on study day 4)
研究者
Prof. Dr. Andreas Rembert Koczulla
Principal investigator
Schön Klinik Berchtesgadener Land