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

Parc Taulí Hospital Universitari

Status

Enrolling

Conditions

SARS CoV 2 Infection

Apnea, Obstructive Sleep

Treatments

Biological: Influvac Tetra

Study type

Observational

Funder types

Other

Identifiers

NCT06341374

2023/5079

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

50 participants in 4 patient groups

Participants who have had severe COVID-19 infection with sleep disturbance

Description:

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.

Treatment:

Biological: Influvac Tetra

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

Description:

Participants with severe COVID19 infection and no currently diagnosed sleep disorders

Treatment:

Biological: Influvac Tetra

Participants who have had mild COVID-19 infection with sleep disturbance

Description:

Participants who have had a mild COVID19 infection and have been diagnosed with a sleep disorder

Treatment:

Biological: Influvac Tetra