Sleep Characteristics in Post-COVID-19 Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Post-COVID-19
• Intervention / Treatment: Diagnostic test: Sleep diagnostics

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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Germany
  • Schönau Am Königssee, Germany, 83471
    • Schoen Klinik Berchtesgadener Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls	Diagnostic test: Sleep 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.
Post-COVID condition	Diagnostic test: Sleep 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Schön Klinik Berchtesgadener Land

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): November 28, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Polysomnography; SARS-CoV-2 infection; Chronic fatigue; REM sleep; Whoop strap
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: WHOOP Sleep

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No