Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
NCT ID: NCT05981183
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-08-09
2026-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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 = 300 μs, frequency = 25 Hz.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prisoners
* Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.
* Not capable of informed consent
* Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)
* ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)
* Recent myocardial infarction (4 weeks or less)
* Maintenance dialysis
* Epilepsy
* Patients on labetalol (labetalol will interfere with catecholamine measurements)
* Patients with diabetes
* At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.
18 Years
80 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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David Charytan, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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23-00778
Identifier Type: -
Identifier Source: org_study_id