Atrial Fibrillation, PersistentNCT05944575
Effect of taVNS on Heart Rate in Persistent Atrial Fibrillation
A study testing active taVNS in people with Atrial Fibrillation, Persistent, run by Burrell College of Health Sciences at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigate the effects of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in patients with persistent atrial fibrillation. taVNS is a treatment through which a small electrical current is applied to a specific location of the left ear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Persistent atrial fibrillation
- On anti-coagulation throughout the study
Who cannot join
- Below 18 years of age
- Pregnancy
- Signs or history of vestibulocochlear neuronitis or nerve damage (e.g., hearing loss or tinnitus)
- Signs or history of epilepsy
- Not on anti-coagulation
Trial locations and contacts
1 site in 1 country.
United States1 site
Burrell College of Osteopathic Medicine
Las Cruces, New Mexico, 88001
Harald M Stauss, MD, PhD, 575-674-2327, hstauss@bcomnm.org
About this study
Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Ventricular Rate Control in Patients With Persistent Atrial Fibrillation
The goal of this clinical trial is to investigate the effects of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in patients with persistent atrial fibrillation. taVNS is a treatment through which a small electrical current is applied to a specific location of the left ear. The main question to answer is whether taVNS will reduce the heart rate in patients with persistent atrial fibrillation. After appropriate training, participants will self-administer taVNS for 30 minutes every day for two weeks. During one of the two weeks (randomized order), the clip electrode, delivering the electrical current will be attached to the cymba conchae of the left ear, while during the other week the clip electrode will be attached to the lobule of the left ear. During both weeks, the electrocardiogram (ECG) will be monitored continuously through a small ECG patch that is placed on the chest. Participants will meet with the investigators at the beginning of the study, after 7 days and at the end of the study (after 14 days). Researchers will compare the ECG obtained during the two weeks and evaluate if the heart rate differs between the two study weeks.
Read the detailed description
In a previous study (Dalgleish et al., 2021), the investigators found that taVNS lengthens the PQ-interval in healthy study participants with regular sinus rhythm. This finding indicates that taVNS slows AV-conduction. Thus, it is reasonable to assume that taVNS may lower ventricular rate in patients with persistent atrial fibrillation. This assumption is in line with a recent study (Stavarakis et al., 2020) demonstrating reduced atrial fibrillation burden in patients with paroxysmal atrial fibrillation in response to a 6-month taVNS intervention.
The investigators hypothesize that taVNS reduces ventricular rate in patients with persistent atrial fibrillation. This hypothesis is based on the finding that taVNS lengthens the PQ-interval in healthy individuals with sinus rhythm (Dalgleish et al., 2021), demonstrating that taVNS slows AV-nodal conduction. Thus, it is conceivable that taVNS reduces the number of atrial excitations that are transmitted into the ventricles in patients with persistent atrial fibrillation. This effect should result in a lower ventricular rate. Testing this hypothesis is significant, because if the hypothesis would be verified, taVNS would have the potential to elicit an additive effect to AV-nodal blocking agents, and thus, may allow to reduce the dose of such drugs, effectively reducing potential adverse effects.
The study is designed as a two-week randomized cross-over study. Participants will start with either taVNS or sham-taVNS (randomly assigned) during the first week and then switch to the other intervention during the second week of the study. Throughout the two-week study, ambulatory ECG will be recorded using an ECG patch that allows continuous ECG recording for up to 14 days. Participants will self-apply taVNS or sham-taVNS for 30 min every day throughout the 2-week study.
Participants will meet with the investigators 3 times throughout the 2-week study protocol: On the first study day, participants will be instrumented with the ECG patch and instructed in the use of the taVNS device. In addition, patients will be instructed to keep a diary to record the time of the taVNS/sham-taVNS application, the stimulation parameters, and any potential therapeutic or adverse effects. The second study visit will occur at the end of the first study week. During this meeting, the function of the ECG patch and taVNS device will be verified, the diary will be inspected to verify protocol adherence, and the intervention will be switched to either taVNS or sham-taVNS application (depending on randomization). The final study visit will occur at the end of the study (after 2 weeks). The ECG patch will be retrieved, and the diary inspected for protocol adherence.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- active taVNS, sham-taVNS
- Keywords
- vagus nerve stimulation, Electrocardiogram, Heart rate
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active taVNSDevice
The clip electrode will be attached to the cymba conchae of the left ear, the location of the auricular branch of the vagus nerve.
sham-taVNSDevice
The clip electrode will be attached to the lobule of the left ear that is not innervated by the auricular branch of the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Active comparator | Participants will self-administer active taVNS for 30 min per day for 7 days. Receives: Device: active taVNS |
| Sham Intervention | Sham comparator | Participants will self-administer sham-taVNS for 30 min per day for 7 days. Receives: Device: sham-taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly ventricular rate
The average ventricular rate (obtained from the ECG patch) during the week with active taVNS (active intervention arm) will be compared with the average ventricular rate during the week with sham-taVNS (sham intervention arm).
Measured: After one week of treatment or sham treatment
Ventricular rate during taVNS application
The ventricular rate (obtained from the ECG patch) during the 30 min of taVNS application will be compared with the ventricular rate during the 30 min of sham-taVNS application for each of the 7 days of each study arm.
Measured: During 30 minutes of treatment or sham treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start7 Aug 2023 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Treatment for each patient will crossover (after one week) from an active taVNS to an inactive sham-taVNS treatment or vice versa (depending on randomization).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burrell College of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harald Stauss MD PhD, Burrell College of Health Sciences
- Investigators
- Harald M Stauss, MD, PhD, Principal investigator, Burrell College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944575
- Sponsor's protocol ID
- 0104_2022
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We do not plan to make individual participant data available to other researchers.
Publications
Dalgleish AS, Kania AM, Stauss HM, Jelen AZ. Occipitoatlantal decompression and noninvasive vagus nerve stimulation slow conduction velocity through the atrioventricular node in healthy participants. J Osteopath Med. 2021 Feb 18;121(4):349-359. doi: 10.1515/jom-2020-0213.
PubMed 33694346Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. JACC Clin Electrophysiol. 2020 Mar;6(3):282-291. doi: 10.1016/j.jacep.2019.11.008. Epub 2020 Jan 29.
PubMed 32192678
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Ventricular Rate Control in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05944575
- Acronym / sponsor ID
- 0104_2022
- Conditions
- Atrial Fibrillation, Persistent
- Keywords
- vagus nerve stimulation, Electrocardiogram, Heart rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Burrell College of Health SciencesUniversity, hospital or other
- Study start
- 7 Aug 2023 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the effects of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) in patients with persistent atrial fibrillation. taVNS is a treatment through which a small electrical current is applied to a specific location of the left ear. The main question to answer is whether taVNS will reduce the heart rate in patients with persistent atrial fibrillation. After appropriate training, participants will self-administer taVNS for 30 minutes every day for two weeks. During one of the two weeks (randomized order), the clip electrode, delivering the electrical current will be attached to the cymba conchae of the left ear, while during the other week the clip electrode will be attached to the lobule of the left ear. During both weeks, the electrocardiogram (ECG) will be monitored continuously through a small ECG patch that is placed on the chest. Participants will meet with the investigators at the beginning of the study, after 7 days and at the end of the study (after 14 days). Researchers will compare the ECG obtained during the two weeks and evaluate if the heart rate differs between the two study weeks.
Detailed description
In a previous study (Dalgleish et al., 2021), the investigators found that taVNS lengthens the PQ-interval in healthy study participants with regular sinus rhythm. This finding indicates that taVNS slows AV-conduction. Thus, it is reasonable to assume that taVNS may lower ventricular rate in patients with persistent atrial fibrillation. This assumption is in line with a recent study (Stavarakis et al., 2020) demonstrating reduced atrial fibrillation burden in patients with paroxysmal atrial fibrillation in response to a 6-month taVNS intervention.
The investigators hypothesize that taVNS reduces ventricular rate in patients with persistent atrial fibrillation. This hypothesis is based on the finding that taVNS lengthens the PQ-interval in healthy individuals with sinus rhythm (Dalgleish et al., 2021), demonstrating that taVNS slows AV-nodal conduction. Thus, it is conceivable that taVNS reduces the number of atrial excitations that are transmitted into the ventricles in patients with persistent atrial fibrillation. This effect should result in a lower ventricular rate. Testing this hypothesis is significant, because if the hypothesis would be verified, taVNS would have the potential to elicit an additive effect to AV-nodal blocking agents, and thus, may allow to reduce the dose of such drugs, effectively reducing potential adverse effects.
The study is designed as a two-week randomized cross-over study. Participants will start with either taVNS or sham-taVNS (randomly assigned) during the first week and then switch to the other intervention during the second week of the study. Throughout the two-week study, ambulatory ECG will be recorded using an ECG patch that allows continuous ECG recording for up to 14 days. Participants will self-apply taVNS or sham-taVNS for 30 min every day throughout the 2-week study.
Participants will meet with the investigators 3 times throughout the 2-week study protocol: On the first study day, participants will be instrumented with the ECG patch and instructed in the use of the taVNS device. In addition, patients will be instructed to keep a diary to record the time of the taVNS/sham-taVNS application, the stimulation parameters, and any potential therapeutic or adverse effects. The second study visit will occur at the end of the first study week. During this meeting, the function of the ECG patch and taVNS device will be verified, the diary will be inspected to verify protocol adherence, and the intervention will be switched to either taVNS or sham-taVNS application (depending on randomization). The final study visit will occur at the end of the study (after 2 weeks). The ECG patch will be retrieved, and the diary inspected for protocol adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Treatment for each patient will crossover (after one week) from an active taVNS to an inactive sham-taVNS treatment or vice versa (depending on randomization).
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Active comparator | Device: active taVNSParticipants will self-administer active taVNS for 30 min per day for 7 days. |
| Sham Intervention | Sham comparator | Device: sham-taVNSParticipants will self-administer sham-taVNS for 30 min per day for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Persistent atrial fibrillation
- On anti-coagulation throughout the study
Key exclusion criteria (5 listed)
- Below 18 years of age
- Pregnancy
- Signs or history of vestibulocochlear neuronitis or nerve damage (e.g., hearing loss or tinnitus)
- Signs or history of epilepsy
- Not on anti-coagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active taVNSThe clip electrode will be attached to the cymba conchae of the left ear, the location of the auricular branch of the vagus nerve. | Device | Active Intervention |
| sham-taVNSThe clip electrode will be attached to the lobule of the left ear that is not innervated by the auricular branch of the vagus nerve. | Device | Sham Intervention |
Primary outcome
Weekly ventricular rate
Time frame: After one week of treatment or sham treatment
The average ventricular rate (obtained from the ECG patch) during the week with active taVNS (active intervention arm) will be compared with the average ventricular rate during the week with sham-taVNS (sham intervention arm).
Ventricular rate during taVNS application
Time frame: During 30 minutes of treatment or sham treatment
The ventricular rate (obtained from the ECG patch) during the 30 min of taVNS application will be compared with the ventricular rate during the 30 min of sham-taVNS application for each of the 7 days of each study arm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Background: PubMed 33694346Dalgleish AS, Kania AM, Stauss HM, Jelen AZ. Occipitoatlantal decompression and noninvasive vagus nerve stimulation slow conduction velocity through the atrioventricular node in healthy participants. J Osteopath Med. 2021 Feb 18;121(4):349-359. doi: 10.1515/jom-2020-0213.
- Background: PubMed 32192678Stavrakis S, Stoner JA, Humphrey MB, Morris L, Filiberti A, Reynolds JC, Elkholey K, Javed I, Twidale N, Riha P, Varahan S, Scherlag BJ, Jackman WM, Dasari TW, Po SS. TREAT AF (Transcutaneous Electrical Vagus Nerve Stimulation to Suppress Atrial Fibrillation): A Randomized Clinical Trial. JACC Clin Electrophysiol. 2020 Mar;6(3):282-291. doi: 10.1016/j.jacep.2019.11.008. Epub 2020 Jan 29.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald M Stauss, MD, PhD principal investigator
Burrell College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active taVNS in people with Atrial Fibrillation, Persistent, run by Burrell College of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harald M Stauss, MD, PhD (575-674-2327, hstauss@burrell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly ventricular rate (time frame: After one week of treatment or sham treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944575, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.