Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Study Details
Study Description
Brief Summary
The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention A Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention A, the pulse width = 250 μs, and frequency = 50 Hz. |
Device: Transcutaneous electrical nerve stimulation unit (TENS)
The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.
Other Names:
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| Experimental: Intervention B Participants will receive 15 minutes of taVNS after an initial 15 minute rest-period and a 15 minute baseline measurement period. For participants assigned to Intervention B, the pulse width = 500 μs, frequency = 25 Hz. |
Device: Transcutaneous electrical nerve stimulation unit (TENS)
The TENS unit will be applied to participants' right ear at the cymba conchae. The dose is dependent on which arm (Intervention A or Intervention B) the participant is assigned to. Participants will undergo 15 minutes of vagal nerve stimulation.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Heart Rate Variability (HRV) at Baseline [Day 1 (15 minutes prior to administration of intervention)]
HRV is the variation in the time interval between heartbeats.
- HRV at Post-Intervention [Day 1 (15 minutes Post-Intervention)]
HRV is the variation in the time interval between heartbeats.
Secondary Outcome Measures
- Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention [Day 1 (Up to 15 Minutes Post-Intervention)]
The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement.
- Blood Pressure at Baseline [Day 1 (15 minutes prior to administration of intervention)]
Blood pressure measured continuously for 15 minutes prior to intervention.
- Blood Pressure at Post-Intervention [Day 1 (15 minutes Post-Intervention)]
Blood pressure measured continuously for 15 minutes post-intervention.
- Spontaneous Baroreceptor Sensitivity (BRS) at Baseline [Day 1 (15 minutes prior to administration of intervention)]
Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
- Spontaneous BRS at Post-Intervention [Day 1 (15 minutes Post-Intervention)]
Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
- Heart Rate at Baseline [Day 1 (15 minutes prior to administration of intervention)]
- Heart Rate at Post-Intervention [Day 1 (15 minutes Post-Intervention)]
Eligibility Criteria
Criteria
Inclusion Criteria:
• Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.
Exclusion Criteria:
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Pacemaker dependent
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Prisoners
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Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.
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Not capable of informed consent
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Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)
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ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)
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Recent myocardial infarction (4 weeks or less)
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Maintenance dialysis
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Epilepsy
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Patients on labetalol (labetalol will interfere with catecholamine measurements)
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Patients with diabetes
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At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 11215 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: David Charytan, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23-00778