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Sleep Characteristics in Post-COVID-19 Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05124548
Enrollment
31
Registered
2021-11-18
Start date
2021-11-25
Completion date
2022-11-29
Last updated
2022-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-COVID-19

Keywords

SARS-CoV-2 infection, REM sleep, Chronic fatigue, Whoop strap, Polysomnography

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.

Interventions

DIAGNOSTIC_TESTSleep diagnostics

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.

Sponsors

Schön Klinik Berchtesgadener Land
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Apnea-Hypopnea-Index (AHI)One single night on study day 4Number of apnea or hypopnea Events per hour of sleep

Secondary

MeasureTime frameDescription
Deep sleep phaseOne single night on study day 4Duration of deep sleep Phase (minutes)
Light sleep phaseOne single night on study day 4Duration of light sleep Phase (minutes)
Periodic leg movement IndexOne single night on study day 4Number of Periodic leg movements per hour of sleep
Rapid Eye Movement (REM) sleep phaseOne single night on study day 4Duration of REM sleep Phase (minutes)
Central apneaOne single night on study day 4Number of central apnea Events per night
Mixed apneaOne single night on study day 4Number of mixed apnea Events per night
Obstructive apneaOne single night on study day 4Number of obstructive apnea Events per night

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026