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

NCT ID: NCT05157334

Last Updated: 2021-12-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Non-invasive auricular electrical transcutaneous vagus nerve stimulation

Intervention Type: 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

Intervention Type: 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.

Interventions

Non-invasive auricular electrical transcutaneous vagus nerve stimulation

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.

Intervention Type: DEVICE

Deep breathing

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University

OTHER

Sponsor Role: collaborator

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Salome Kristensen

Clinical associate professor, Priniciple investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Salome Kristensen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

Aalborg Universitetshospital

Aalborg, North Denmark, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Salome Kristensen, MD, PhD

Role: CONTACT

Phone: + 45 99 32 81 83

Email: sakr@rn.dk

Facility Contacts

Salome Kristensen, MD, PhD

Role: primary

Other Identifiers

N-20210002

Identifier Type: -

Identifier Source: org_study_id