The Effect of Deep Breathing and Transcutaneus Electrical Nerve Stimulation on Heart Rate Variability

Aalborg University Hospital

Status: Unknown

Conditions: Healthy Participants; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Device: Non-invasive auricular electrical transcutaneous vagus nerve stimulation; Other: Deep breathing

Study type: Interventional

Funder types: Other

Identifiers

NCT05157334

N-20210002

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Men and women in the age range from 18 years to 85 years old.
• For subproject 1 and 3 the participants must be diagnosed with either rheumatoid arthritis or systemic lupus erythematosus.
• Must sign and date informed consent.

Exclusion criteria

• Lacking ability to make or understand informed consent.
• Medical history with psychiatric or psychological conditions which the person in charge of the research estimates will affect the participants ability to participate in the study.
• Furthermore participants with severe mental illness will be excluded due to the fact that severe mental illness cause decreased heart rate variability.
• Pregnancy.
• Addict or prior addict defined as abuse of hash, opioids or other euphoriant drugs.
• Known atrial fibrillation or atrial flutter.
• Known chronic lung disease.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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180 participants in 1 patient group

Deep breathing

Experimental group

Description:

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. Sub-project 2: A dose-response study in healthy participants comparing the effect of 5, 15 and 30 minutes of DB on HRV. 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.

Treatment:

Device: Non-invasive auricular electrical transcutaneous vagus nerve stimulation

Other: Deep breathing