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Behavioural Intervention

taVNS for Chronic Kidney Disease

Q: Can individuals over the age of fifty-five sign up for this medical experiment?

This study is recruiting participants aged 18 or above but no older than 80, in line with the inclusion criteria.

Q: Who is the ideal candidate for participating in this research study?

This clinical experiment is open to patients suffering from chronic kidney disease, aged between 18 and 80. Approximately 20 people will be accepted into the trial.

Q: What is the capacity of patients for this research endeavor?

Affirmative. The particulars on clinicaltrials.gov suggest that this research initiative, which was launched on August 7th 2023 is actively recruiting participants. There are currently vacancies for 20 people at a single site.

Q: Is the program open to new participants currently?

Affirmative. Per the information provided on clinicaltrials.gov, this medical study is currently enrolling participants; it was initially published on August 7th 2023 and has been updated since then. This trial needs to recruit 20 patients from 1 centre of care.

N/A

Recruiting

Led By David Charytan, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (15 minutes post-intervention)

Awards & highlights

Study Summary

This trial will investigate the safety, tolerability & effects of a novel therapy (taVNS) for people with chronic kidney disease to reduce their risk of heart problems.

Who is the study for?

This trial is for adults aged 18-80 with moderate to severe chronic kidney disease (stages 3-5). It's not suitable for those with pacemakers, prisoners, pregnant women, individuals unable to consent, people with certain nervous system disorders like Parkinson's with autonomic dysfunction, recent heart attack survivors, dialysis patients, epilepsy sufferers or diabetics. Also excluded are those on labetalol medication or if over half the group is taking beta blockers.Check my eligibility

What is being tested?

The study tests a non-invasive ear device that stimulates the vagus nerve using electrical impulses in two different doses. The goal is to see if it's safe and tolerable and whether it could help reduce heart-related deaths in people with chronic kidney disease. This pilot will guide the design of a larger future study.See study design

What are the potential side effects?

While specific side effects aren't listed here, transcutaneous electrical nerve stimulation can sometimes cause skin irritation at the site of application and may lead to discomfort or pain during use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old with moderate to severe chronic kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (15 minutes post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (15 minutes post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (15 minutes post-intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HRV at Post-Intervention

Heart Rate Variability (HRV) at Baseline

Secondary outcome measures

Blood Pressure at Baseline

Blood Pressure at Post-Intervention

Heart Rate at Baseline

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention BExperimental Treatment1 Intervention

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.

Group II: Intervention AExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,369 Previous Clinical Trials

840,578 Total Patients Enrolled

David Charytan, MDPrincipal InvestigatorNYU Langone Health

2 Previous Clinical Trials

17 Total Patients Enrolled

Media Library

Transcutaneous Auricular Vagus Nerve Stimulation Device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05981183 — N/A

Chronic Kidney Disease Research Study Groups: Intervention A, Intervention B

Chronic Kidney Disease Clinical Trial 2023: Transcutaneous Auricular Vagus Nerve Stimulation Device Highlights & Side Effects. Trial Name: NCT05981183 — N/A

Transcutaneous Auricular Vagus Nerve Stimulation Device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05981183 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals over the age of fifty-five sign up for this medical experiment?

"This study is recruiting participants aged 18 or above but no older than 80, in line with the inclusion criteria."

Answered by AI

Who is the ideal candidate for participating in this research study?

"This clinical experiment is open to patients suffering from chronic kidney disease, aged between 18 and 80. Approximately 20 people will be accepted into the trial."

Answered by AI

What is the capacity of patients for this research endeavor?

"Affirmative. The particulars on clinicaltrials.gov suggest that this research initiative, which was launched on August 7th 2023 is actively recruiting participants. There are currently vacancies for 20 people at a single site."

Answered by AI

Is the program open to new participants currently?

"Affirmative. Per the information provided on clinicaltrials.gov, this medical study is currently enrolling participants; it was initially published on August 7th 2023 and has been updated since then. This trial needs to recruit 20 patients from 1 centre of care."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

2023. "Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05981183.