Sleep Characteristics in Post-COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sleep Characteristics in Post-Corona Virus Disease 2019 Patients Compared to Healthy Controls - An Observational Trial

Conditions
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Post-COVID-19

Intervention / Treatment
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* Diagnostic Test: Sleep diagnostics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-COVID condition<br> | Diagnostic Test: Sleep diagnostics<br>* On study day 4, all participants perform a single night sleep assessment in a sleep lab via Polysomnography (PSG) and WHOOP strap, a digital Fitness and health Coach.<br>|
| Healthy controls<br> | Diagnostic Test: Sleep diagnostics<br>* On study day 4, all participants perform a single night sleep assessment in a sleep lab via Polysomnography (PSG) and WHOOP strap, a digital Fitness and health Coach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea-Index (AHI) | Number of apnea or hypopnea Events per hour of sleep | One single night on study day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rapid Eye Movement (REM) sleep phase | Duration of REM sleep Phase (minutes) | One single night on study day 4 | 
| Deep sleep phase | Duration of deep sleep Phase (minutes) | One single night on study day 4 | 
| Light sleep phase | Duration of light sleep Phase (minutes) | One single night on study day 4 | 
| Periodic leg movement Index | Number of Periodic leg movements per hour of sleep | One single night on study day 4 | 
| Obstructive apnea | Number of obstructive apnea Events per night | One single night on study day 4 | 
| Central apnea | Number of central apnea Events per night | One single night on study day 4 | 
| Mixed apnea | Number of mixed apnea Events per night | One single night on study day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-CoV-2 infection, REM sleep, Chronic fatigue, Whoop strap, Polysomnography