SARS CoV 2 Infection Clinical Trial
Official title:
Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients. A Cohort Study
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | September 30, 2024 |
| Est. primary completion date | March 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari Parc Tauli | Sabadell | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Parc Taulí Hospital Universitari |
Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |
| Secondary | 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. | |
| Secondary | 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. | |
| Secondary | 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. |