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

Recruiting

• Conditions: SARS CoV 2 Infection; Apnea, Obstructive Sleep
• Interventions: Biological: Influvac Tetra

• Registration Number: NCT06341374
• Lead Sponsor: Parc Taulí Hospital Universitari

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.

Study Timeline

• Study Start: 2023-11-06
• Status Verified: 2024-03
• Study First Submitted: 2024-03-29
• Study First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Primary Completion: 2024-03-30
• Study First Posted: 2024-04-02
• Last Update Posted: 2024-04-02
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants who have had mild COVID-19 infection without sleep disorder	Influvac Tetra	Participants who have had a mild COVID19 infection and have not been diagnosed with a sleep disorder
Participants who have had severe COVID-19 infection with sleep disturbance	Influvac Tetra	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.
Participants who have had mild COVID-19 infection with sleep disturbance	Influvac Tetra	Participants who have had a mild COVID19 infection and have been diagnosed with a sleep disorder
Participants who have had severe COVID-19 infection without sleep disorder	Influvac Tetra	Participants with severe COVID19 infection and no currently diagnosed sleep disorders

Primary Outcome Measures

Name	Time	Method
Immunological study: cytokines.	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 Outcome Measures

Name	Time	Method
Epigenetic modification.	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
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.	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
Diagnostic of obstructive sleep apnea in selected cohort	It is an overnight study that will last for one night.	Night home sleep study with WatchPAT® 300.

Trial Locations

Locations (1)

Hospital Universitari Parc Tauli; 🇪🇸 Sabadell, Barcelona, Spain