Clinical trial NCT06341374: Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients
Official title: Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients. A Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Apnea, Obstructive Sleep
SARS CoV 2 Infection
Keywords: Obstructive Sleep Apnea
Innate immunity
SARS-CoV-2
Lead sponsor: Parc Taulí Hospital Universitari
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Immunological study: cytokines.
timeFrame: To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.
Secondary outcomes:
measure: Innate cells: monocytes, classical dendritic cells and Natural Killer cells.
timeFrame: To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.
measure: Epigenetic modification.
timeFrame: To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.
measure: Diagnostic of obstructive sleep apnea in selected cohort
timeFrame: It is an overnight study that will last for one night.
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Tauli
state: Barcelona
Study officials:
affiliation: Hospital Universitari Parc Tauli, Sabadell
name: Maria Jose M Masdeu, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari Parc Tauli, Sabadell
name: Andrea F Grau, Medicine
role: PRINCIPAL_INVESTIGATOR
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