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

NCT06341374 | Recruiting

• 1 other identifier: 2023/5079
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea, Obstructive Sleep; SARS CoV 2 Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• Epigenetic modification.

  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

  It is an overnight study that will last for one night.

Study Arms (4)

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.

Biological: Influvac Tetra

Participants who have had severe COVID-19 infection without sleep disorder

Participants with severe COVID19 infection and no currently diagnosed sleep disorders

Biological: Influvac Tetra

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

Biological: Influvac Tetra

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

Biological: Influvac Tetra

Interventions

Influvac Tetra BIOLOGICAL

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 mild COVID-19 infection without sleep disorder; Participants who have had severe COVID-19 infection with sleep disturbance; Participants who have had severe COVID-19 infection without sleep disorder

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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).

You may qualify if:

• Participants over 18 years old with diagnosis of COVID-19 during first year of coronavirus pandemic in March-June 2021.

You may not qualify if:

• \>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

Sponsors & Collaborators

• Parc Taulí Hospital Universitari: lead

Study Sites (1)

Hospital Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

RECRUITING

Related Publications (11)

• 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.

  PMID: 26762182 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.

  PMID: 27510422 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.

  PMID: 30920354 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.

  PMID: 12243633 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.

  PMID: 34903540 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.

  PMID: 34098591 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.

  PMID: 32437659 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.

  PMID: 21575907 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.

  PMID: 34315886 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.

  PMID: 31427444 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.

  PMID: 34695164 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; COVID-19

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases

Study Officials

• Maria Jose M Masdeu, Medicine

  Hospital Universitari Parc Tauli, Sabadell

  PRINCIPAL INVESTIGATOR

• Andrea F Grau, Medicine

  Hospital Universitari Parc Tauli, Sabadell

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea F Grau, Medicine

CONTACT

+34608151458; andreagrau94@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonology medical specialist

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 2, 2024
• Study Start: November 6, 2023
• Primary Completion: March 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)