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

Not Applicable

• Conditions: Healthy Participants; Rheumatoid Arthritis; Systemic Lupus Erythematosus
• Interventions: Device: Non-invasive auricular electrical transcutaneous vagus nerve stimulation; Other: Deep breathing

• Registration Number: NCT05157334
• Lead Sponsor: Aalborg University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-11-02
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-12
• Last Update Submitted: 2021-12-12
• Study First Posted: 2021-12-15
• Last Update Posted: 2021-12-15
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Deep breathing	Non-invasive auricular electrical transcutaneous vagus nerve stimulation	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.
Deep breathing	Deep breathing	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.

Primary Outcome Measures

Name	Time	Method
Heart rate variability root mean square of successive R-R intervals (RMSSD)	HRV is measured with five ECG recordings, each lasting 5 min. Two measurements with 5 minutes apart are made just prior to the 30 minutes of deep breathing/tvns. Three measurements are made after the intervention, separated by 7,5 minutes each.	Heart rate variability is used as a surrogate measure of vagus nerve activity. The primary outcome is changes in the HRV-parameter RMSSD

Secondary Outcome Measures

Name	Time	Method
Heart rate variability standard deviation of the R-R intervals (SDNN) and pairs of successive R-R intervals that differ more than 50 milliseconds divided by the total number of R-R intervals (PNN50)	HRV is measured before and after 30 minutes of deep breathing/tvns.	Heart rate variability is used as a surrogate measure of vagus nerve activity - change in PNN50, SDNN

Trial Locations

Locations (1)

Aalborg Universitetshospital; 🇩🇰 Aalborg, Region Nordjylland, Denmark