Chronic Kidney DiseaseNCT05981183
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
A study testing Transcutaneous electrical nerve stimulation unit (TENS) in people with Chronic Kidney Disease, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Transcutaneous electrical nerve stimulation unit (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 11215
About this study
Official title: A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
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.
- Conditions
- Chronic Kidney Disease
- Being tested
- Transcutaneous electrical nerve stimulation unit (TENS)
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation unit (TENS)Device
Also called TENS Device 7000
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention A | Experimental | 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. Receives: Device: Transcutaneous electrical nerve stimulation unit (TENS) |
| Intervention B | Experimental | 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. Receives: Device: Transcutaneous electrical nerve stimulation unit (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability (HRV) at Baseline
HRV is the variation in the time interval between heartbeats.
Measured: Day 1 (15 minutes prior to administration of intervention)
HRV at Post-Intervention
HRV is the variation in the time interval between heartbeats.
Measured: Day 1 (15 minutes Post-Intervention)
Secondary outcomes (7)
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.
Measured: Day 1 (Up to 15 Minutes Post-Intervention)
Blood Pressure at Baseline
Blood pressure measured continuously for 15 minutes prior to intervention.
Measured: Day 1 (15 minutes prior to administration of intervention)
Blood Pressure at Post-Intervention
Blood pressure measured continuously for 15 minutes post-intervention.
Measured: Day 1 (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.
Measured: Day 1 (15 minutes prior to administration of intervention)
Spontaneous BRS at Post-Intervention
Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure.
Measured: Day 1 (15 minutes Post-Intervention)
Heart Rate at Baseline
Measured: Day 1 (15 minutes prior to administration of intervention)
Heart Rate at Post-Intervention
Measured: Day 1 (15 minutes Post-Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start9 Aug 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Charytan, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981183
- Sponsor's protocol ID
- 23-00778
- Status last verified
- Nov 2026
- First submitted
- 1 Aug 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
- ClinicalTrials.gov ID
- NCT05981183
- Acronym / sponsor ID
- 23-00778
- Conditions
- Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 8 Aug 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention A | Experimental | Device: Transcutaneous electrical nerve stimulation unit (TENS)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. |
| Intervention B | Experimental | Device: Transcutaneous electrical nerve stimulation unit (TENS)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| Transcutaneous electrical nerve stimulation unit (TENS)Also: TENS Device 7000The 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. | Device | Intervention A, Intervention B |
Primary outcome
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.
HRV at Post-Intervention
Time frame: Day 1 (15 minutes Post-Intervention)
HRV is the variation in the time interval between heartbeats.
7 secondary outcomes
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)
Blood Pressure at Baseline
Time frame: Day 1 (15 minutes prior to administration of intervention)
Blood Pressure at Post-Intervention
Time frame: Day 1 (15 minutes Post-Intervention)
Spontaneous Baroreceptor Sensitivity (BRS) at Baseline
Time frame: Day 1 (15 minutes prior to administration of intervention)
Spontaneous BRS at Post-Intervention
Time frame: Day 1 (15 minutes Post-Intervention)
Heart Rate at Baseline
Time frame: Day 1 (15 minutes prior to administration of intervention)
Heart Rate at Post-Intervention
Time frame: Day 1 (15 minutes Post-Intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
David Charytan, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation unit (TENS) in people with Chronic Kidney Disease, run by NYU Langone Health 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 1 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Charytan, MD ((646) 501-9086, David.charytan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (HRV) at Baseline (time frame: Day 1 (15 minutes prior to administration of intervention)). 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?
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 5 Nov 2026.