Obstructive Sleep Apnea in Patients With Long COVID-19 Fatigue: a Multicentre Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 12
- 主要终点
- post-COVID-19 long term fatigue and OSA
研究概览
简要总结
Identify the relationship of obstructive sleep apnea (OSA) prevalence with post-COVID-19 fatigue that remains at least six months after acute disease
详细描述
The presence of fatigue symptoms up to 6-7 months after acute COVID-19 disease, similar to myalgic encephalomyelitis/chronic fatigue syndrome, also observed after other viral infections, have been reported as the most frequent post-COVID-19 symptom (Townsend et al., 2020).
There is a physiological plausibility for OSA being a causal factor to COVID-19 morbidity and fatigue symptoms by nocturnal hypoxemia, exacerbating or causing endothelial dysfunction, inflammation, oxidative stress, microaspiration and cardiac dysfunction. OSA activates the renin-angiotensin-aldosterone system (RAAS) and angiotensin-converting enzyme-2 (ACE2), which is the SARS-CoV-2 entry receptor in the cells (Miller et al., 2021).
In this study we will identify the prevalence of OSA and it's relation with post-COVID-19 fatigue that remains for at least six month after the acute disease, in patients that attend the post-COVID-19 Out Patients Hospital Clinics. It will be studied also the relation between fatigue and vaccination status, nocturnal hypoxemia, day time sleepness and the acute COVID-19 severity.
Data collection will be performed by a questionnaire administered by qualified clinical study staff (i.e., by physicians who conduct the post-COVID-19 medical consultation).
Demographic, clinical data and clinical research forms will be collected between 6-7th month after the diagnosis of COVID-19 (t1) and 9 months later (t2).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) ≥18 years; (2) previous COVID-19 at least six months before the initial study protocol evaluation; (3) persistent symptoms after cure criteria defined by WHO; (4) patients who attend the post-COVID-19 follow-up consultation of the study centers. (5) SARS-CoV-2 infection confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab (6) patients who agree to sign the Written informed consent (following the ethics committee protocol).
排除标准
- •(1) patients who had a concomitant neurological disorder that could increase OSA risk (such as stroke, Parkinson disease, or amyotrophic lateral sclerosis); (2) patients who were on invasive mechanical ventilation. (3) patients with persistent fatigue symptoms,6 months before SARS-CoV-2 infection (4) patients without SARS-CoV-2 positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab
结局指标
主要结局
post-COVID-19 long term fatigue and OSA
时间窗: 6 - 7 months
Evaluate if untreated OSA is associated with post COVID-19 long term fatigue.
次要结局
- post-COVID-19 long term fatigue and nocturnal hypoxemia(6 - 7 months)
- post-COVID-19 long term fatigue and severity of acute COVID-19(6 - 9 months)
- post-COVID-19 long term fatigue and vaccination status(6 - 9 months)
- Long COVID-19 and OSA impact in quality of life(6 - 7 months)
- post-COVID-19 long term fatigue and daytime sleepiness(6 - 9 months)
研究者
Ligia Pires
Principal Investigator
Centro Hospitalar Universitario do Algarve