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

Breath-assisted stimulation of the anti-inflammatory reflex of the vagus nerve in covid-19 disease: a randomized-controlled trial - BEAT-COVID (Breathing against COVID)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00023971
Enrollment
60
Registered
2021-02-02
Start date
2021-02-21
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inpatients, hospitalized due to infection with SARS-CoV-2 U07.1

Interventions

Group 1: Intervention: Breathing exercise to stimulate vagal activity to stimulate the cholinergic anti-inflammatory reflex. Aim: 3x20min daily with 6 breaths per minute and an inhale to exhale ratio

Sponsors

Klinik für Psychosomatische Medizin und Psychotherapie, Uniklinik Ulm
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Germany

Contacts

Public ContactElisabeth Balint

Klinik für Psychosomatische Medizin und Psychotherapie, Uniklinikum Ulm

elisabeth.balint@uni-ulm.de+49 (0)731 500-61904

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026