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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Participants who have had severe COVID-19 infection without sleep disorder | Participants with severe COVID19 infection and no currently diagnosed sleep disorders |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influvac Tetra | Biological | All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunological study: cytokines. | To measure in blood: IL-1 beta, IL-6, IL-8, IL-10, TNF-alfa, IFN-alfa, IFN-gamma, GM-CSF. | To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later. |
| Measure | Description | Time Frame |
|---|---|---|
| Innate cells: monocytes, classical dendritic cells and Natural Killer cells. | 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 | To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea F Grau, Medicine | Contact | +34608151458 | andreagrau94@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maria Jose M Masdeu, Medicine | Hospital Universitari Parc Tauli, Sabadell | Principal Investigator |
| Andrea F Grau, Medicine | Hospital Universitari Parc Tauli, Sabadell | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Parc Tauli | Recruiting | Sabadell | Barcelona | 08208 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26762182 | Background | 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. | |
| 27510422 | Background | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Epigenetic modification. | To measure: H3K4me3, H3K4me1 and H3K27Ac | To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later. |
| Diagnostic of obstructive sleep apnea in selected cohort | Night home sleep study with WatchPAT® 300. | It is an overnight study that will last for one night. |
| 30920354 | Background | 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. |
| 12243633 | Background | 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. |
| 34903540 | Background | 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. |
| 34098591 | Background | 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. |
| 32437659 | Background | 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. |
| 21575907 | Background | 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. |
| 34315886 | Background | 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. |
| 31427444 | Background | 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. |
| 34695164 | Background | 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. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |