Back to resultsTranscutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Primary Purpose
Chronic Kidney Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation unit (TENS)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
Eligibility 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.
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention A
Intervention B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Heart Rate Variability (HRV) at Baseline
HRV is the variation in the time interval between heartbeats.
HRV at 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
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
Blood pressure measured continuously for 15 minutes prior to intervention.
Blood Pressure at Post-Intervention
Blood pressure measured continuously for 15 minutes post-intervention.
Spontaneous Baroreceptor Sensitivity (BRS) at Baseline
Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
Spontaneous BRS at 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
Heart Rate at Post-Intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05981183
Brief Title
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Official Title
A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2023 (Actual)
Primary Completion Date
August 7, 2025 (Anticipated)
Study Completion Date
August 7, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention A
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation unit (TENS)
Other Intervention Name(s)
TENS Device 7000
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart Rate Variability (HRV) at Baseline
Description
HRV is the variation in the time interval between heartbeats.
Time Frame
Day 1 (15 minutes prior to administration of intervention)
Title
HRV at Post-Intervention
Description
HRV is the variation in the time interval between heartbeats.
Time Frame
Day 1 (15 minutes Post-Intervention)
Secondary Outcome Measure Information:
Title
Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention
Description
The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement.
Time Frame
Day 1 (Up to 15 Minutes Post-Intervention)
Title
Blood Pressure at Baseline
Description
Blood pressure measured continuously for 15 minutes prior to intervention.
Time Frame
Day 1 (15 minutes prior to administration of intervention)
Title
Blood Pressure at Post-Intervention
Description
Blood pressure measured continuously for 15 minutes post-intervention.
Time Frame
Day 1 (15 minutes Post-Intervention)
Title
Spontaneous Baroreceptor Sensitivity (BRS) at Baseline
Description
Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
Time Frame
Day 1 (15 minutes prior to administration of intervention)
Title
Spontaneous BRS at Post-Intervention
Description
Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
Time Frame
Day 1 (15 minutes Post-Intervention)
Title
Heart Rate at Baseline
Time Frame
Day 1 (15 minutes prior to administration of intervention)
Title
Heart Rate at Post-Intervention
Time Frame
Day 1 (15 minutes Post-Intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Charytan, MD
Phone
(646) 501-9086
Email
David.charytan@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Qandeel Soomro, MD
Phone
(212) 263-7300
Email
Qandeel.soomro@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Charytan, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
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