Apnea, Obstructive SleepNCT06341374
Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients
An observational study of Apnea, Obstructive Sleep and SARS CoV 2 Infection, run by Parc Taulí Hospital Universitari at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Apnea, Obstructive Sleep, SARS CoV 2 Infection
- What is being tested?
- Influvac Tetra
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 6 Nov 2023to 30 Sep 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Participants over 18 years old with diagnosis of COVID-19 during first year of coronavirus pandemic in March-June 2021.
Who cannot join
- >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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Parc Tauli
Sabadell, Barcelona, 08208
Andrea F Grau, Medicine, +34608151458, andreagrau94@gmail.com
Miguel D Gallego, Medicine, +34616315290, mgallego@tauli.cat
About this study
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.
Read the 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.
- Conditions
- Apnea, Obstructive Sleep, SARS CoV 2 Infection
- Being tested
- Influvac Tetra
- Keywords
- Obstructive Sleep Apnea, Innate immunity, SARS-CoV-2
- Medical subject headings
- Sleep Apnea, Obstructive, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influvac TetraBiological
All participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: 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 Receives: Biological: Influvac Tetra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological study: cytokines.
To measure in blood: IL-1 beta, IL-6, IL-8, IL-10, TNF-alfa, IFN-alfa, IFN-gamma, GM-CSF.
Measured: 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 measure: monocytes (CD45, CD14, CD16, HLA-DR), classical dendritic cells (CD45, CD1c, CD141, CD11c, CD86) and NK cells (CD45, CD56, CD16, Pan-KIR2D, NKG2D
Measured: To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.
Epigenetic modification.
To measure: H3K4me3, H3K4me1 and H3K27Ac
Measured: 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.
Measured: It is an overnight study that will last for one night.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start6 Nov 2023
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Apnea, Obstructive SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Parc Taulí Hospital Universitari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Grau Freixinet, Parc Taulí Hospital Universitari
- Investigators
- Maria Jose M Masdeu, Medicine, Principal investigator, Hospital Universitari Parc Tauli, SabadellAndrea F Grau, Medicine, Principal investigator, Hospital Universitari Parc Tauli, Sabadell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341374
- Sponsor's protocol ID
- 2023/5079
- Status last verified
- Mar 2024
- First submitted
- 29 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26762182Irwin 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.
PubMed 27510422Besedovsky 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.
PubMed 30920354Spiegel 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.
PubMed 12243633Partinen 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.
PubMed 34903540Park 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.
PubMed 34098591Netea 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.
PubMed 32437659Netea 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.
PubMed 21575907Laupeze 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.
PubMed 34315886Wagstaffe 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.
PubMed 31427444Debisarun 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.
PubMed 34695164
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sleep Disorders on Innate Immunity in COVID-19 Patients. A Cohort Study
- ClinicalTrials.gov ID
- NCT06341374
- Acronym / sponsor ID
- 2023/5079
- Conditions
- Apnea, Obstructive Sleep, SARS CoV 2 Infection
- Keywords
- Obstructive Sleep Apnea, Innate immunity, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Parc Taulí Hospital UniversitariUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants who have had severe COVID-19 infection with sleep disturbance | – | Biological: Influvac TetraThis 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. |
| Participants who have had severe COVID-19 infection without sleep disorder | – | Biological: Influvac TetraParticipants with severe COVID19 infection and no currently diagnosed sleep disorders |
| Participants who have had mild COVID-19 infection with sleep disturbance | – | Biological: Influvac TetraParticipants 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 | – | Biological: Influvac TetraParticipants who have had a mild COVID19 infection and have not been diagnosed with a sleep disorder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Participants over 18 years old with diagnosis of COVID-19 during first year of coronavirus pandemic in March-June 2021.
Key exclusion criteria (5 listed)
- >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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influvac TetraAll participants will take influenza vaccine (Influvac Tetra, Abbott Biologicals, IL, USA) and the trained immune response will be evaluated. | Biological | 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 |
Primary outcome
Immunological study: cytokines.
Time frame: 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.
3 secondary outcomes
Innate cells: monocytes, classical dendritic cells and Natural Killer cells.
Time frame: To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.
Epigenetic modification.
Time frame: 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
Time frame: It is an overnight study that will last for one night.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 26762182Borbely 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.
- Background: PubMed 27510422Irwin 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.
- Background: PubMed 30920354Besedovsky 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.
- Background: PubMed 12243633Spiegel 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.
- Background: PubMed 34903540Partinen 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.
- Background: PubMed 34098591Park 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.
- Background: PubMed 32437659Netea 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.
- Background: PubMed 21575907Netea 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.
- Background: PubMed 34315886Laupeze 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.
- Background: PubMed 31427444Wagstaffe 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.
- Background: PubMed 34695164Debisarun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Jose M Masdeu, Medicine principal investigator
Hospital Universitari Parc Tauli, Sabadell
Andrea F Grau, Medicine principal investigator
Hospital Universitari Parc Tauli, Sabadell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, Obstructive Sleep and SARS CoV 2 Infection, run by Parc Taulí Hospital Universitari at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea F Grau, Medicine (+34608151458, andreagrau94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological study: cytokines. (time frame: To evaluate immune response blood samples will be taken at the time influenza vaccine is given, 7 and 30 days later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06341374, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.