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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention A | Experimental | 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. |
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| Intervention B | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability (HRV) at Baseline | HRV is the variation in the time interval between heartbeats. | Day 1 (15 minutes prior to administration of intervention) |
| HRV at Post-Intervention | HRV is the variation in the time interval between heartbeats. | Day 1 (15 minutes Post-Intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with at least a 20% change in HRV from baseline to post-intervention | The percentage of participants whose measured HRV changes by more than 20% from the baseline measurement to the post-intervention measurement. | Day 1 (Up to 15 Minutes Post-Intervention) |
| Blood Pressure at Baseline |
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Inclusion Criteria:
• Individual 18-80 years of age with CKD stage 3-5 (eGFR <60 mL/min/1.73m2) on most recent outpatient labs.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Charytan, MD | Contact | (646) 501-9086 | David.charytan@nyulangone.org | |
| Qandeel Soomro, MD | Contact | (212) 263-7300 | Qandeel.soomro@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| David Charytan, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 11215 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: David.Charytan@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to David.Charytan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Blood pressure measured continuously for 15 minutes prior to intervention. |
| Day 1 (15 minutes prior to administration of intervention) |
| Blood Pressure at Post-Intervention | Blood pressure measured continuously for 15 minutes post-intervention. | Day 1 (15 minutes Post-Intervention) |
| Spontaneous Baroreceptor Sensitivity (BRS) at Baseline | Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure. | Day 1 (15 minutes prior to administration of intervention) |
| Spontaneous BRS at Post-Intervention | Spontaneous BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in blood pressure. | Day 1 (15 minutes Post-Intervention) |
| Heart Rate at Baseline | Day 1 (15 minutes prior to administration of intervention) |
| Heart Rate at Post-Intervention | Day 1 (15 minutes Post-Intervention) |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |