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Clinical Trials/NCT06341374
NCT06341374
Recruiting
Not Applicable

Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients. A Cohort Study

Parc Taulí Hospital Universitari1 site in 1 country50 target enrollmentNovember 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Apnea, Obstructive Sleep
Sponsor
Parc Taulí Hospital Universitari
Enrollment
50
Locations
1
Primary Endpoint
Immunological study: cytokines.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Sleep is an important modulator of the immune response, whereby sleep disturbances (ie, poor sleep quality, insufficient sleep and/or primary sleep disorder, obstructive sleep apnea (OSA)) contribute to inflammatory disease risk and dysregulation of immune response in front of infectious agents.

The objective of this study is to evaluate the impact of undiagnosed and non-treated sleep disorders on innate immunity in a cohort of COVID-19 patients and the role of trained immunity induced by influenza vaccination in the innate immune response.

Detailed Description

Sleep and immune system have reciprocal relationship. Sleep has a restorative role on immune system, influencing innate and adaptive immunity and sleep disorders can decrease immune response. Healthy innate immunity is crucial into regulation of the response against SARS-CoV-2. The hypothesis of the study is that the innate immunity response is blunted by sleep disorders and, this mitigated immune response, could influence on COVID-19 severity. Impaired immune response in patients with sleep disorders could be ameliorated inducing trained immunity by influenza vaccine.

Registry
clinicaltrials.gov
Start Date
November 6, 2023
End Date
September 30, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Parc Taulí Hospital Universitari
Responsible Party
Principal Investigator
Principal Investigator

Andrea Grau Freixinet

Pulmonology medical specialist

Parc Taulí Hospital Universitari

Eligibility Criteria

Inclusion Criteria

  • Participants over 18 years old with diagnosis of COVID-19 during first year of coronavirus pandemic in March-June 2021.

Exclusion Criteria

  • \>70 years and \<18 years
  • Recent COVID-19 (\<6 months)
  • Other infection (\<3 months)
  • Obstructive sleep apnea in treatment with CPAP prior to COVID infection.
  • Immunosuppressed

Outcomes

Primary Outcomes

Immunological study: cytokines.

Time Frame: To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.

To measure in blood: IL-1 beta, IL-6, IL-8, IL-10, TNF-alfa, IFN-alfa, IFN-gamma, GM-CSF.

Secondary Outcomes

  • Epigenetic modification.(To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.)
  • Innate cells: monocytes, classical dendritic cells and Natural Killer cells.(To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.)
  • Diagnostic of obstructive sleep apnea in selected cohort(It is an overnight study that will last for one night.)

Study Sites (1)

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