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

NCT05157334 | Unknown

• 1 other identifier: N-20210002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Systemic Lupus Erythematosus; Healthy Participants

Keywords

Heart rate variability; Deep breathing; Transcutaneous vagus nerve stimulation; Vagus nerve stimulation; Breathing exercises

Outcome Measures

Primary Outcomes (1)

• Heart rate variability root mean square of successive R-R intervals (RMSSD)

  Heart rate variability is used as a surrogate measure of vagus nerve activity. The primary outcome is changes in the HRV-parameter 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.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Deep breathing

EXPERIMENTAL

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.

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

Interventions

Non-invasive auricular electrical transcutaneous vagus nerve stimulation DEVICE

A NEMOS ® stimulator (Cerbomed, Erlangen, Germany) is used for transcutaneous auricular vagus nerve stimulation. This is a handheld battery driven stimulator which stimulates conca in the outer ear. It stimulates in a serie of small electrical impulses with a pulse width at 250 us and a frequency at 25 Hz for 30 minutes in a cycle for 30 seconds "on" and 30 seconds "off" to avoid habituation. It is previously indicated that a stimulation intensity at 0,5 mA, 1 mA or 1,5 mA does not cause a significant chance in HRV, thus 0,5 mA is used in this study.

Deep breathing

Deep breathing OTHER

The participant is first verbally introduced to the breathing exercises, and then to the visually cue (animation), which the participant have to follow throughout the session.

Deep breathing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Aalborg University: collaborator

Study Sites (1)

Aalborg Universitetshospital

Aalborg, North Denmark, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Salome Kristensen, MD, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salome Kristensen, MD, PhD

CONTACT

+ 45 99 32 81 83; sakr@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor, Priniciple investigator, MD, PhD

Model Details: Sub-project 1: Randomized crossover study Sub-project 2: Randomized parallel Sub-project 3: Single groupe

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: December 15, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

DK (1)