Skip to main content
Clinical Trials/NCT05124548
NCT05124548
Completed
Not Applicable

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

Schön Klinik Berchtesgadener Land1 site in 1 country31 target enrollmentNovember 25, 2021
ConditionsPost-COVID-19

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-COVID-19
Sponsor
Schön Klinik Berchtesgadener Land
Enrollment
31
Locations
1
Primary Endpoint
Apnea-Hypopnea-Index (AHI)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 25, 2021
End Date
November 29, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Andreas Rembert Koczulla

Principal investigator

Schön Klinik Berchtesgadener Land

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

Outcomes

Primary Outcomes

Apnea-Hypopnea-Index (AHI)

Time Frame: One single night on study day 4

Number of apnea or hypopnea Events per hour of sleep

Secondary Outcomes

  • 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)

Study Sites (1)

Loading locations...

Similar Trials