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Can Manipulation of the Vagus Nerve Through Deep Breathing and Transcutaneus Electrical Nerve Stimulation Modulate Heart Rate Variability?
This interventional study aims to investigate the effect of deep breathing (DB) and transcutaneous electrical vagus nerve stimulation (tVNS) on heart rate variability (HRV) in healthy participants and patients with rheumatoid arthritis (RA) or systemic lupus erythematosus (SLE). HRV is used as a surrogate measure of vagal nerve tone. The study consists of three sub-projects: Sub-project 1: To compare the effect of one session of DB and one session of non-invasive auricular tVNS on vagal nerve tone measured by HRV in healthy participants and in patients with RA and SLE. The hypotheses is that DB has a similar effect on HRV as non-invasive electrical tVNS. Sub-project 2: A dose-response study in healthy participants comparing the effect of 5, 15 and 30 minutes of DB on HRV. The hypothesis was that HRV increases as a function of the number of minutes the DB is performed in healthy participants. Sub-project 3: To investigate the effect of the optimal dose found in sub-project 2 in patients with RA and SLE measured by HRV, and to investigate its reproducibility by doing it twice.The hypothesis was that HRV increases after DB in patients with RA and SLE, and the effect is reproducible. In all three sub-projects the washout period will be investigated by measuring HRV three times after the intervention. We hypothesise that the effect of DB and tVNS on HRV decreases over time.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
Yes
Aalborg Universitetshospital
Aalborg, North Denmark, Denmark
Start Date
September 1, 2021
Primary Completion Date
September 1, 2022
Completion Date
September 1, 2022
Last Updated
December 15, 2021
180
ESTIMATED participants
Non-invasive auricular electrical transcutaneous vagus nerve stimulation
DEVICE
Deep breathing
OTHER
Lead Sponsor
Aalborg University Hospital
Collaborators
NCT06647069
NCT07484243
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