Transcutaneous Auricular Vagal Neuromodulation Therapy (AVNT™) in Chronic Kidney Disease Autonomic Dysfunction

November 4, 2026 updated by: NYU Langone Health

Feasibility and Preliminary Efficacy of Transcutaneous Auricular Vagal Neuromodulation Therapy (AVNT™) in Chronic Kidney Disease Autonomic Dysfunction: A Randomized, Sham-Controlled Pilot Trial (Parasym-CKD)

The purpose of this pilot study is to establish the feasibility of home-based Auricular Vagal Neuromodulation Therapy (AVNT™) in Chronic Kidney Disease (CKD) patients, generate preliminary efficacy data on autonomic function outcomes, and explore whether timing variation influences treatment response.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years at time of informed consent
  2. Documented Chronic Kidney Disease (CKD) stage G3-G5 (estimated Glomerular Filtration Rate (eGFR) 15-59 mL/min/1.73 m²), not on maintenance dialysis, based on eGFR or clinical documentation
  3. Patients at New York University (NYU) clinics who meet criteria
  4. Non NYU patients reaching out study team via iConnect
  5. Clinically stable: No hospitalization, acute kidney injury, or acute illness requiring medical intervention within prior 4 weeks
  6. Stable dosing of autonomically active medications: participants taking beta-blockers, other rate-controlling agents, anticholinergics, or sympathomimetics must be on a stable dose for ≥4 weeks before baseline with no anticipated changes during the study. Use of these agents is recorded and included as a covariate in analyses of heart-rate-based endpoints. Autonomically active medications: agents that materially affect heart rate, blood pressure, or autonomic tone - beta-blockers, non-dihydropyridine calcium-channel blockers, alpha-blockers, central sympatholytics (e.g., clonidine), midodrine, fludrocortisone, anticholinergics, sympathomimetics/stimulants, serotonin-norepinephrine reuptake inhibitors (SNRIs)/selective serotonin reuptake inhibitors (SSRIs), and diuretics are recorded with agent, dose, and timing, must be stable for ≥4 weeks before baseline with no anticipated change during the study, and are included as covariates. Home measurements are taken at a consistent time relative to the participant's usual dosing.

Exclusion Criteria:

  1. Implantable cardioverter-defibrillator (ICD) or other implanted cardiac device

  2. Known severe coronary disease (≥70% stenosis in major vessel) or myocardial infarction within past 5 years

  3. Hospitalized within 4 weeks

  4. Syncope or unexplained loss of consciousness within past 12 months

  5. Uncontrolled arrhythmia (atrial fibrillation with resting heart rate >110 bpm, recent runs of sustained ventricular tachycardia or supraventricular tachycardia) within 3 months.

  6. Severe bradycardia (<40 bpm at rest, symptomatic) , or second- or third-degree atrioventricular (AV) block without a functioning pacemaker

  7. Neurological/Anatomical Exclusions:

  8. History of vagotomy (surgical cutting of vagus nerve)

  9. Trigeminal neuralgia within 1 year

  10. Epilepsy or seizure disorder (unless well-controlled defined as seizure free with stable dose of medication for ≥2 years)

  11. Dementia or cognitive impairment preventing informed consent or study compliance

    Renal/General Medical Exclusions:

  12. End-stage kidney disease (ESKD) on maintenance hemodialysis or peritoneal dialysis

  13. Pregnancy or breastfeeding

  14. Active malignancy (except non-melanoma skin cancer)

  15. Severe hepatic disease (Child-Pugh Class C cirrhosis)

  16. Immunosuppression (within 8 weeks of enrollment) or active immunosuppressive therapy

    Skin/Electrode-Related Exclusions:

  17. Active infection or severe lesions at tragus preventing electrode placement

  18. Known allergy to gold or electrode materials

  19. Implanted device at <2 cm proximity to ear tragus (e.g., cochlear implant, cerebral shunt, invasive Vagus Nerve Stimulation (VNS))

    Substance Use/Other:

  20. Active substance uses disorder (within 1 year) or alcohol use >14 drinks/week

  21. Participation in another clinical trial within 30 days

  22. Any condition that, in the investigator's judgment, would make participation unsafe or preclude compliance

  23. Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Sham-AM

Participants will use the sham-device for 1 hr/day at 7:00 AM.
Device: Sham-device

The device is equipped with a "ramp-down sham mode". In this mode, no electrical stimulation will occur for the remainder of the session and participant intensity adjustments are disabled. Participants will use the sham-device at home once daily for 60 minutes either in the morning at 7am or in the evening at 7pm.
Sham Comparator: Sham-PM

Participants will use the sham-device for 1 hr/day at 7:00 PM.
Device: Sham-device

The device is equipped with a "ramp-down sham mode". In this mode, no electrical stimulation will occur for the remainder of the session and participant intensity adjustments are disabled. Participants will use the sham-device at home once daily for 60 minutes either in the morning at 7am or in the evening at 7pm.
Experimental: Active-AM

Participants will use the active AVNT device for 1 hr/day at 7:00 AM.
Device: Auricular Vagal Neuromodulation Therapy (AVNT™)

The device consists of a handheld stimulation unit (~2 inches) connected to a tragus earpiece electrode (worn like an in-ear headphone, removed after each session). Participants will undergo AVNT™ at home once daily for 60 minutes either in the morning at 7am or in the evening at 7pm at a pulse width of 250 μs, frequency of 20 Hz, and comfortable, patient-titrated intensity based on personalized perceptual thresholds.

Other Names:
  • Nurosym
Experimental: Active-PM

Participants will use the active AVNT device for 1 hr/day at 7:00 PM.
Device: Auricular Vagal Neuromodulation Therapy (AVNT™)

The device consists of a handheld stimulation unit (~2 inches) connected to a tragus earpiece electrode (worn like an in-ear headphone, removed after each session). Participants will undergo AVNT™ at home once daily for 60 minutes either in the morning at 7am or in the evening at 7pm at a pulse width of 250 μs, frequency of 20 Hz, and comfortable, patient-titrated intensity based on personalized perceptual thresholds.

Other Names:
  • Nurosym

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Orthostatic Heart Rate Response
Time Frame: Week 0, Week 2

Difference in standing heart rate at 1 minute minus baseline seated heart rate, averaged across daily home measurements in Week 0 (baseline) and last 3-5 days of Week 2 (post-intervention).
Week 0, Week 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in high-sensitivity C-reactive protein (hs-CRP) (pg/mL)
Time Frame: Week 0, Week 2
Week 0, Week 2
Change in Interleukin-6 (IL-6) (pg/mL)
Time Frame: Week 0, Week 2
Week 0, Week 2
Change in Urine Albumin-Creatinine Ratio (UACR) (mg/g creatinine)
Time Frame: Week 0, Week 2
Week 0, Week 2
Change in Composite Autonomic Symptom Score-31 (COMPASS-31)
Time Frame: Week 0, Week 2

The COMPASS-31 is a 31-item, self-administered clinical questionnaire used to measure the severity and distribution of autonomic nervous system symptoms (dysautonomia). Scores range from 0 to 100, where higher scores indicate worse autonomic dysfunction.
Week 0, Week 2
Percentage of participants who achieved ≥85% prescribed minutes (714 of 840 min)
Time Frame: Week 2
Week 2
Percentage of patients that completed ≥70% of scheduled autonomic measurements
Time Frame: Week 2
Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qandeel Soomro, MD, MS, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-00938

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

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 granted access upon reasonable request. Requests should be directed to Qandeel.Soomro@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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