Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD)

NCT ID: NCT06927024

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-15

Study Completion Date

2029-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active taVNS

Participants receive two weeks of 15-minute taVNS daily in the morning.

Group Type EXPERIMENTAL

Active taVNS

Intervention Type DEVICE

Active taVNS delivered via the TENS Device 7000.

Sham taVNS

Participants receive two weeks of 15-minute sham intervention daily in the morning.

Group Type SHAM_COMPARATOR

Sham taVNS

Intervention Type DEVICE

Sham taVNS delivered via the TENS Device 7000.

Interventions

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Active taVNS

Active taVNS delivered via the TENS Device 7000.

Intervention Type DEVICE

Sham taVNS

Sham taVNS delivered via the TENS Device 7000.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Presence of an implantable defibrillators
* Presence of a permanent pacemaker
* Unable to consent
* Incarcerated individuals
* Pregnant individuals
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Qandeel Soomro, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Qandeel Soomro, MD

Role: CONTACT

Phone: (212) 263-7300

Email: [email protected]

David Charytan, MD

Role: CONTACT

Phone: (646) 501-9086

Email: [email protected]

Facility Contacts

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Qandeel Soomro, MD

Role: primary

Other Identifiers

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1K23DK139462-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-00756

Identifier Type: -

Identifier Source: org_study_id