Breath-assisted stimulation of the anti-inflammatory reflex of the vagus nerve in covid-19 disease: a randomized-controlled trial

Not Applicable

• Conditions: Inpatients, hospitalized due to infection with SARS-CoV-2; U07.1; COVID-19, virus identified

• Registration Number: DRKS00023971
• Lead Sponsor: Klinik für Psychosomatische Medizin und Psychotherapie, Uniklinik Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-02
• Study Completion: 2022-07-22
• Results First Posted: 2022-10-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

SARS-CoV-2-infected patients hospitalized in normal wards (Not ICU) with a maximum moderate degree of disease according to RKI/WHO definition (see first exclusion criterion)
- Age min. 18 years
- Able to give informed consent at the time of study inclusion

Exclusion Criteria

- severe covid pneumonia with fever and bilateral lung infiltrates and respiratory rate>30/min or SpO2<90% on room air (adapted from RKI/WHO)
- Condition after surgery/trauma/acute event (stroke, myocardial infarction, acute covid-independent infection) in the last 4 weeks
- Known pregnancy
- Patients with pre-existing pulmonary disease who were on oxygen prior to infection (e.g., due to pulmonary fibrosis, COPD)
- limited ability to give consent (e.g. due to dementia)
- limited ability to perform breathing maneuvers independently (e.g. high frailty)
- limited ability to provide self-care (care level 2 or 3)
- lack of language skills
- seizures in the medical history

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Course of inflammatory parameter IL-6 at admission (day 1) and bi-daily until discharge (average length of stay 10 days, i.e. 5 measurements on average)

Secondary Outcome Measures

Name	Time	Method
1.) Course of other inflammatory parameters leukocytes, CRP, TNF-alpha (Bi-daily)<br>2) subjective dyspnea on admission (day 1) and for two days until discharge (5 measurements), day 30 after discharge<br>3.) Onset of ventilator requirement and intensive care requirement within 30 days of first hospitalization and death by 30 days after discharge<br>4.) Length of stay in normal ward <br>5.) Course of SDNN (recorded on admission and then bi-daily)<br>6.) Outpatient course (query of Covid-19-associated symptoms such as fatigue 30 days after discharge)<br>