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Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

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ClinicalTrials.gov Identifier: NCT05981183
Recruitment Status : Recruiting
First Posted : August 8, 2023
Last Update Posted : September 8, 2023
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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
Chronic Kidney Disease Device: Transcutaneous electrical nerve stimulation unit (TENS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Actual Study Start Date : August 7, 2023
Estimated Primary Completion Date : August 7, 2025
Estimated Study Completion Date : August 7, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: TENS Device 7000
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 = 300 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 Name: TENS Device 7000


Outcome Measures
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Primary Outcome Measures :
  1. Heart Rate Variability (HRV) at Baseline [ Time Frame: Day 1 (15 minutes prior to administration of intervention) ]
    HRV is the variation in the time interval between heartbeats.

  2. HRV at Post-Intervention [ Time Frame: Day 1 (15 minutes Post-Intervention) ]
    HRV is the variation in the time interval between heartbeats.


Secondary Outcome Measures :
  1. Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention [ Time Frame: 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.

  2. Blood Pressure at Baseline [ Time Frame: Day 1 (15 minutes prior to administration of intervention) ]
    Blood pressure measured continuously for 15 minutes prior to intervention.

  3. Blood Pressure at Post-Intervention [ Time Frame: Day 1 (15 minutes Post-Intervention) ]
    Blood pressure measured continuously for 15 minutes post-intervention.

  4. Spontaneous Baroreceptor Sensitivity (BRS) at Baseline [ Time Frame: 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.

  5. Spontaneous BRS at Post-Intervention [ Time Frame: 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.

  6. Heart Rate at Baseline [ Time Frame: Day 1 (15 minutes prior to administration of intervention) ]
  7. Heart Rate at Post-Intervention [ Time Frame: Day 1 (15 minutes Post-Intervention) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • Pacemaker dependent
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05981183


Contacts
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Contact: David Charytan, MD (646) 501-9086 David.charytan@nyulangone.org
Contact: Qandeel Soomro, MD (212) 263-7300 Qandeel.soomro@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 11215
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: David Charytan, MD NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05981183    
Other Study ID Numbers: 23-00778
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: September 8, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.Charytan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to David.Charytan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes