Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients

March 29, 2024 updated by: Andrea Grau Freixinet, Parc Taulí Hospital Universitari

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Participants will be selected from the local cohort database COVID-19 (Department of Epidemiology) which includes those patients who received medical care at the Hospital Universitari Parc Taulí during the first year of the coronavirus pandemic in March-June 2021.

Participants will be classified with or without sleep disorders based on the results of nocturnal pulse oximetry (WatchPAT).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants who have had severe COVID-19 infection with sleep disturbance

This cohort of participants will be recruited from participants in ongoing study in our institution (CEIm 2021/5096) where exploring contributions of sleep disorders on severity of COVID-19.

To explore present sleep status participants will be asked to fill out sleep questionnaires referred to their sleep characteristics since COVID-19 episode until present moment. As objective evaluation of sleep participants will perform a night home sleep study with WatchPAT® 300 sleep recording, Itamar Medical Ltd.

Cohort 1 will be those participants who have had a severe COVID19 infection and have been diagnosed with a sleep disorder.
Biological: Influvac Tetra
All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.
Participants who have had severe COVID-19 infection without sleep disorder
Participants with severe COVID19 infection and no currently diagnosed sleep disorders
Biological: Influvac Tetra
All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.
Participants who have had mild COVID-19 infection with sleep disturbance
Participants who have had a mild COVID19 infection and have been diagnosed with a sleep disorder
Biological: Influvac Tetra
All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.
Participants who have had mild COVID-19 infection without sleep disorder
Participants who have had a mild COVID19 infection and have not been diagnosed with a sleep disorder
Biological: Influvac Tetra
All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Innate cells: monocytes, classical dendritic cells and Natural Killer cells.
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: monocytes (CD45, CD14, CD16, HLA-DR), classical dendritic cells (CD45, CD1c, CD141, CD11c, CD86) and NK cells (CD45, CD56, CD16, Pan-KIR2D, NKG2D
To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.
Epigenetic modification.
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: H3K4me3, H3K4me1 and H3K27Ac
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
Time Frame: It is an overnight study that will last for one night.
Night home sleep study with WatchPAT® 300.
It is an overnight study that will last for one night.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc Taulí Hospital Universitari

Investigators

  • Principal Investigator: Maria Jose M Masdeu, Medicine, Hospital Universitari Parc Taulí, Sabadell
  • Principal Investigator: Andrea F Grau, Medicine, Hospital Universitari Parc Taulí, Sabadell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/5079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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