NCT05124548

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

November 25, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2022

Completed
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

November 17, 2021

Last Update Submit

November 29, 2022

Conditions

Post-COVID-19

Keywords

SARS-CoV-2 infectionREM sleepChronic fatigueWhoop strapPolysomnography

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea-Index (AHI)

    Number of apnea or hypopnea Events per hour of sleep

    One single night on study day 4

Secondary Outcomes (7)

  • Rapid Eye Movement (REM) sleep phase

    One single night on study day 4

  • Deep sleep phase

    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

  • +2 more secondary outcomes

Study Arms (2)

Post-COVID condition

Diagnostic Test: Sleep diagnostics

Healthy controls

Diagnostic Test: Sleep diagnostics

Interventions

Sleep diagnosticsDIAGNOSTIC_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.

Healthy controlsPost-COVID condition

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 17, 2021

First Posted

November 18, 2021

Study Start

November 25, 2021

Primary Completion

November 28, 2022

Study Completion

November 29, 2022

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations

DE(1)