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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK139462-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active taVNS | Experimental | Participants receive two weeks of 15-minute taVNS daily in the morning. |
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| Sham taVNS | Sham Comparator | Participants receive two weeks of 15-minute sham intervention daily in the morning. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active taVNS | Device | Active taVNS delivered via the TENS Device 7000. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients who Complete 2 Weeks of Intervention | Proportion of patients who use the device for 2 weeks (14 sessions). Measure of feasibility. | Week 2 |
| Proportion of Patients who Tolerate Each Full 15-Minute Session | Proportion of patients who use the device for 2 weeks (14 sessions), 15 minutes per session. Measure of feasibility | Week 2 |
| Incidence of Severe Bradycardia following taVNS Use | Severe bradycardia defined as heart rate (HR) <50 beats per minute. Measure of safety. | Up to Week 2 |
| Incidence of Severe Tachycardia following taVNS Use | Severe tachycardia defined as heart rate (HR) >100 beats per minute. Measure of safety. | Up to Week 2 |
| Incidence of Syncope following taVNS Use | Measure of safety. | Up to Week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eligible patients who consent to use the device for 2 weeks | Also known as "recruitment yield." Measure of feasibility. | Up to Week 2 |
| Change in High Frequency (HF) Signal from Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qandeel Soomro, MD | Contact | (212) 263-7300 | Qandeel.Soomro@nyulangone.org | |
| David Charytan, MD | Contact | (646) 501-9086 | David.Charytan@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Qandeel Soomro, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
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.
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 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.
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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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| Sham taVNS |
| Device |
Sham taVNS delivered via the TENS Device 7000. |
|
HF defined as vagal heart rate variation (HRV) modulation. Measure of efficacy.
| Baseline, Week 2 |
| 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 |