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Completed

NCT Number: NCT05124548

Sleep Characteristics in Post-COVID-19 Patients

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.

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Key information

Conditions

Post-COVID-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep diagnostics

Diagnostic Test

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.

Primary outcomes

  1. 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

  1. Rapid Eye Movement (REM) sleep phase

    Time frame: One single night on study day 4

    Duration of REM sleep Phase (minutes)

  2. Deep sleep phase

    Time frame: One single night on study day 4

    Duration of deep sleep Phase (minutes)

  3. Light sleep phase

    Time frame: One single night on study day 4

    Duration of light sleep Phase (minutes)

  4. Periodic leg movement Index

    Time frame: One single night on study day 4

    Number of Periodic leg movements per hour of sleep

  5. Obstructive apnea

    Time frame: One single night on study day 4

    Number of obstructive apnea Events per night

  6. Central apnea

    Time frame: One single night on study day 4

    Number of central apnea Events per night

  7. Mixed apnea

    Time frame: One single night on study day 4

    Number of mixed apnea Events per night

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2021
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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