Clinical trial NCT05157334: The Effect of Deep Breathing and Transcutaneus Electrical Nerve Stimulation on Heart Rate Variability
Official title: Can Manipulation of the Vagus Nerve Through Deep Breathing and Transcutaneus Electrical Nerve Stimulation Modulate Heart Rate Variability?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Systemic Lupus Erythematosus
Healthy Participants
Keywords: Heart rate variability
Deep breathing
Transcutaneous vagus nerve stimulation
Vagus nerve stimulation
Breathing exercises
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2021-12-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Sub-project 1: Randomized crossover study Sub-project 2: Randomized parallel Sub-project 3: Single groupe
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Heart rate variability root mean square of successive R-R intervals (RMSSD)
timeFrame: 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:
measure: 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)
timeFrame: HRV is measured before and after 30 minutes of deep breathing/tvns.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
state: Region Nordjylland
Study officials:
affiliation: Aalborg University Hospital
name: Salome Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: