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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06341374
Enrollment
50
Registered
2024-04-02
Start date
2023-11-06
Completion date
2024-09-30
Last updated
2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Obstructive Sleep, SARS CoV 2 Infection

Keywords

Obstructive Sleep Apnea, Innate immunity, SARS-CoV-2

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.

Interventions

BIOLOGICALInfluvac Tetra

All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.

Sponsors

Parc Taulí Hospital Universitari
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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
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
Diagnostic of obstructive sleep apnea in selected cohortIt is an overnight study that will last for one night.Night home sleep study with WatchPAT® 300.

Countries

Spain

Contacts

Primary ContactAndrea F Grau, Medicine
andreagrau94@gmail.com+34608151458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026