Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients
NCT ID: NCT06341374
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2023-11-06
2024-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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
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
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
Influvac Tetra
All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.
Interventions
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Influvac Tetra
All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Recent COVID-19 (\<6 months)
* Other infection (\<3 months)
* Obstructive sleep apnea in treatment with CPAP prior to COVID infection.
* Immunosuppressed
18 Years
70 Years
ALL
Yes
Sponsors
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Parc Taulí Hospital Universitari
OTHER
Responsible Party
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Andrea Grau Freixinet
Pulmonology medical specialist
Principal Investigators
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Maria Jose M Masdeu, Medicine
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Parc Tauli, Sabadell
Andrea F Grau, Medicine
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Parc Tauli, Sabadell
Locations
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Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Borbely AA, Daan S, Wirz-Justice A, Deboer T. The two-process model of sleep regulation: a reappraisal. J Sleep Res. 2016 Apr;25(2):131-43. doi: 10.1111/jsr.12371. Epub 2016 Jan 14.
Irwin MR, Opp MR. Sleep Health: Reciprocal Regulation of Sleep and Innate Immunity. Neuropsychopharmacology. 2017 Jan;42(1):129-155. doi: 10.1038/npp.2016.148. Epub 2016 Aug 11.
Besedovsky L, Lange T, Haack M. The Sleep-Immune Crosstalk in Health and Disease. Physiol Rev. 2019 Jul 1;99(3):1325-1380. doi: 10.1152/physrev.00010.2018.
Spiegel K, Sheridan JF, Van Cauter E. Effect of sleep deprivation on response to immunization. JAMA. 2002 Sep 25;288(12):1471-2. doi: 10.1001/jama.288.12.1471-a. No abstract available.
Partinen M, Holzinger B, Morin CM, Espie C, Chung F, Penzel T, Benedict C, Bolstad CJ, Cedernaes J, Chan RNY, Dauvilliers Y, De Gennaro L, Han F, Inoue Y, Matsui K, Leger D, Cunha AS, Merikanto I, Mota-Rolim S, Nadorff M, Plazzi G, Schneider J, Sieminski M, Wing YK, Bjorvatn B. Sleep and daytime problems during the COVID-19 pandemic and effects of coronavirus infection, confinement and financial suffering: a multinational survey using a harmonised questionnaire. BMJ Open. 2021 Dec 13;11(12):e050672. doi: 10.1136/bmjopen-2021-050672.
Park SH. An Impaired Inflammatory and Innate Immune Response in COVID-19. Mol Cells. 2021 Jun 30;44(6):384-391. doi: 10.14348/molcells.2021.0068.
Netea MG, Giamarellos-Bourboulis EJ, Dominguez-Andres J, Curtis N, van Crevel R, van de Veerdonk FL, Bonten M. Trained Immunity: a Tool for Reducing Susceptibility to and the Severity of SARS-CoV-2 Infection. Cell. 2020 May 28;181(5):969-977. doi: 10.1016/j.cell.2020.04.042. Epub 2020 May 4.
Netea MG, Quintin J, van der Meer JW. Trained immunity: a memory for innate host defense. Cell Host Microbe. 2011 May 19;9(5):355-61. doi: 10.1016/j.chom.2011.04.006.
Laupeze B, Del Giudice G, Doherty MT, Van der Most R. Vaccination as a preventative measure contributing to immune fitness. NPJ Vaccines. 2021 Jul 27;6(1):93. doi: 10.1038/s41541-021-00354-z.
Wagstaffe HR, Pickering H, Houghton J, Mooney JP, Wolf AS, Prevatt N, Behrens RH, Holland MJ, Riley EM, Goodier MR. Influenza Vaccination Primes Human Myeloid Cell Cytokine Secretion and NK Cell Function. J Immunol. 2019 Sep 15;203(6):1609-1618. doi: 10.4049/jimmunol.1801648. Epub 2019 Aug 19.
Debisarun PA, Gossling KL, Bulut O, Kilic G, Zoodsma M, Liu Z, Oldenburg M, Ruchel N, Zhang B, Xu CJ, Struycken P, Koeken VACM, Dominguez-Andres J, Moorlag SJCFM, Taks E, Ostermann PN, Muller L, Schaal H, Adams O, Borkhardt A, Ten Oever J, van Crevel R, Li Y, Netea MG. Induction of trained immunity by influenza vaccination - impact on COVID-19. PLoS Pathog. 2021 Oct 25;17(10):e1009928. doi: 10.1371/journal.ppat.1009928. eCollection 2021 Oct.
Other Identifiers
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2023/5079
Identifier Type: -
Identifier Source: org_study_id
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