Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05981183
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcutaneous electrical nerve stimulation unit (TENS) — DEVICE
    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 Details

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.

Key Dates

Start date
Aug 9, 2023
Status verified
Jun 2025
Primary completion
Jan 7, 2026
Completion
Jan 7, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention A
    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.
  • Experimental: Intervention B
    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.

Primary Outcome Measure

Heart Rate Variability (HRV) at Baseline [ Time Frame: Day 1 (15 minutes prior to administration of intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York11215-

Find similar trials in New York, NY

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
NYU Langone Health· New York, NY

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