Clinical trial NCT05124548: Sleep Characteristics in Post-COVID-19 Patients
Official title: Sleep Characteristics in Post-Corona Virus Disease 2019 Patients Compared to Healthy Controls - An Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-COVID-19
Keywords: SARS-CoV-2 infection
REM sleep
Chronic fatigue
Whoop strap
Polysomnography
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients will be included in this study. Patients with Post-COVID-19 (n=15) are characterized by Symptoms usually starting 3 months following the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis than SARS-CoV-2 infection.

Healthy controls are characterized by having no history of SARS-CoV-2 infection.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Apnea-Hypopnea-Index (AHI)
timeFrame: One single night on study day 4
Secondary outcomes:
measure: Rapid Eye Movement (REM) sleep phase
timeFrame: One single night on study day 4
measure: Deep sleep phase
timeFrame: One single night on study day 4
measure: Light sleep phase
timeFrame: One single night on study day 4
measure: Periodic leg movement Index
timeFrame: One single night on study day 4
measure: Obstructive apnea
timeFrame: One single night on study day 4
measure: Central apnea
timeFrame: One single night on study day 4
measure: Mixed apnea
timeFrame: One single night on study day 4
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schoen Klinik Berchtesgadener Land
Study officials:
References: