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Clinical trial

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

ID
Name
2023/5079
Description
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.
Trial arms
Trial start
2023-11-06
Estimated PCD
2024-03-30
Trial end
2024-09-30
Status
Recruiting
Treatment
Influvac Tetra
All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.
Arms:
Participants who have had mild COVID-19 infection with sleep disturbance, Participants who have had mild COVID-19 infection without sleep disorder, Participants who have had severe COVID-19 infection with sleep disturbance, Participants who have had severe COVID-19 infection without sleep disorder
Size
50
Primary endpoint
Immunological study: cytokines.
To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '1 Month', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-04-02

1 organization

1 product

3 indications

Organization
Parc Taulí Hospital Universitari
Product
Influvac Tetra
Indication
Apnea
Indication
Obstructive Sleep Apnea
Indication
COVID-19