Chronic Kidney DiseasesNCT06927024
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)
A study testing Active taVNS in people with Chronic Kidney Diseases, run by NYU Langone Health at 1 site in United States.
Trial summary
30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Active taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to 31 Jan 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals age ≥18 years
- Diagnosis of Chronic Kidney Disease (CKD) stage 3-5 [estimated glomerular filtration rate \≤60 mL/min/1.73m2]
- Receiving care at NYU Nephrology outpatient practice
- Able to provide informed consent
Who cannot join
- Primary ANS disorders (e.g., Parkinson's disease)
- Arrhythmias
- Implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) precluding assessment of HRV (e.g., chronic atrial fibrillation)
- On maintenance dialysis (HD)
- Epilepsy
- Symptomatic bradycardia
Show all 11Show fewer
- Presence of an implantable defibrillators
- Presence of a permanent pacemaker
- Unable to consent
- Incarcerated individuals
- Pregnant individuals
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, 10016
Qandeel Soomro, MD, (212) 263-7300, Qandeel.Soomro@nyulangone.org
About this study
Official title: A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)
30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Active taVNS, Sham taVNS
- 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.
Active taVNSDevice
Active taVNS delivered via the TENS Device 7000.
Sham taVNSDevice
Sham taVNS delivered via the TENS Device 7000.
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS | Experimental | Participants receive two weeks of 15-minute taVNS daily in the morning. Receives: Device: Active taVNS |
| Sham taVNS | Sham comparator | Participants receive two weeks of 15-minute sham intervention daily in the morning. Receives: Device: Sham taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients who Complete 2 Weeks of Intervention
Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility.
Measured: Week 2
Proportion of Patients who Tolerate Each Full 15-Minute Session
Proportion of patients who use the device for 2 weeks (14 sessions), 15 minutes per session. Measure of feasibility
Measured: Week 2
Incidence of Severe Bradycardia following taVNS Use
Severe bradycardia defined as heart rate (HR) <50 beats per minute. Measure of safety.
Measured: Up to Week 2
Incidence of Severe Tachycardia following taVNS Use
Severe tachycardia defined as heart rate (HR) >100 beats per minute. Measure of safety.
Measured: Up to Week 2
Incidence of Syncope following taVNS Use
Measure of safety.
Measured: Up to Week 2
Secondary outcomes (2)
Proportion of eligible patients who consent to use the device for 2 weeks
Also known as "recruitment yield." Measure of feasibility.
Measured: Up to Week 2
Change in High Frequency (HF) Signal from Baseline
HF defined as vagal heart rate variation (HRV) modulation. Measure of efficacy.
Measured: Baseline, Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start15 Oct 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qandeel Soomro, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927024
- Sponsor's protocol ID
- 24-00756
- Other IDs
- 1K23DK139462-01A1
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2025
- Last updated
- 29 Oct 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 will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Qandeel.Soomro@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Sham-controlled Pilot Trial of a Novel Therapeutic Strategy (taVNS) for Autonomic Nervous System (ANS) Dysfunction in Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT06927024
- Acronym / sponsor ID
- 24-00756
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 15 Apr 2025 (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.
30 patients will participate in a prospective randomized clinical trial to test the safety, tolerability and efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for autonomic nervous system (ANS) dysfunction in the chronic kidney disease (CKD) stage 3-5 setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Experimental | Device: Active taVNSParticipants receive two weeks of 15-minute taVNS daily in the morning. |
| Sham taVNS | Sham comparator | Device: Sham taVNSParticipants receive two weeks of 15-minute sham intervention daily in the morning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals age ≥18 years
- Diagnosis of Chronic Kidney Disease (CKD) stage 3-5 [estimated glomerular filtration rate \≤60 mL/min/1.73m2]
- Receiving care at NYU Nephrology outpatient practice
- Able to provide informed consent
Key exclusion criteria (11 listed)
- Primary ANS disorders (e.g., Parkinson's disease)
- Arrhythmias
- Implantable cardioverter-defibrillator (ICD) or pacemaker (PPM) precluding assessment of HRV (e.g., chronic atrial fibrillation)
- On maintenance dialysis (HD)
- Epilepsy
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 |
|---|---|---|
| Active taVNSActive taVNS delivered via the TENS Device 7000. | Device | Active taVNS |
| Sham taVNSSham taVNS delivered via the TENS Device 7000. | Device | Sham taVNS |
Primary outcome
Proportion of Patients who Complete 2 Weeks of Intervention
Time frame: Week 2
Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility.
Proportion of Patients who Tolerate Each Full 15-Minute Session
Time frame: Week 2
Proportion of patients who use the device for 2 weeks (14 sessions), 15 minutes per session. Measure of feasibility
Incidence of Severe Bradycardia following taVNS Use
Time frame: Up to Week 2
Severe bradycardia defined as heart rate (HR) <50 beats per minute. Measure of safety.
Incidence of Severe Tachycardia following taVNS Use
Time frame: Up to Week 2
Severe tachycardia defined as heart rate (HR) >100 beats per minute. Measure of safety.
Incidence of Syncope following taVNS Use
Time frame: Up to Week 2
Measure of safety.
2 secondary outcomes
Proportion of eligible patients who consent to use the device for 2 weeks
Time frame: Up to Week 2
Change in High Frequency (HF) Signal from Baseline
Time frame: Baseline, Week 2
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 29 Oct 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Qandeel.Soomro@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Qandeel Soomro, 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 Active taVNS in people with Chronic Kidney Diseases, 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 4 inclusion and 11 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 29 Oct 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. Some participants in this study may receive a placebo. 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 Qandeel Soomro, MD ((212) 263-7300, Qandeel.Soomro@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients who Complete 2 Weeks of Intervention (time frame: Week 2). The study lists 5 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 29 Oct 2026.