An interventional study of Auricular Vagal Neuromodulation Therapy (AVNT™) and Sham-device in Chronic Kidney Disease (CKD) Stages G3 to G5, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
The purpose of this pilot study is to establish the feasibility of home-based Auricular Vagal Neuromodulation Therapy (AVNT™) in Chronic Kidney Disease (CKD) patients, generate preliminary efficacy data on autonomic function outcomes, and explore whether timing variation influences treatment response.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 30 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dementia or cognitive impairment preventing or study compliance
Renal/General Medical Exclusions:
(within 8 weeks of enrollment) or active immunosuppressive therapy
Skin/Electrode-Related Exclusions:
Implanted device at \<2 cm proximity to ear tragus (e.g., cochlear implant, cerebral shunt, invasive Vagus Nerve Stimulation (VNS))
Substance Use/Other:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use the sham-device for 1 hr/day at 7:00 AM.
Device: Sham-device
Participants will use the sham-device for 1 hr/day at 7:00 PM.
Device: Sham-device
Participants will use the active AVNT device for 1 hr/day at 7:00 AM.
Device: Auricular Vagal Neuromodulation Therapy (AVNT™)
Participants will use the active AVNT device for 1 hr/day at 7:00 PM.
Device: Auricular Vagal Neuromodulation Therapy (AVNT™)
The device consists of a handheld stimulation unit (\~2 inches) connected to a tragus earpiece electrode (worn like an in-ear headphone, removed after each session). Participants will undergo AVNT™ at home once daily for 60 minutes either in the morning at 7am or in the evening at 7pm at a pulse width of 250 μs, frequency of 20 Hz, and comfortable, patient-titrated intensity based on personalized perceptual thresholds.
Also known as: Nurosym
The device is equipped with a "ramp-down sham mode". In this mode, no electrical stimulation will occur for the remainder of the session and participant intensity adjustments are disabled. Participants will use the sham-device at home once daily for 60 minutes either in the morning at 7am or in the evening at 7pm.
Change in Orthostatic Heart Rate Response
Difference in standing heart rate at 1 minute minus baseline seated heart rate, averaged across daily home measurements in Week 0 (baseline) and last 3-5 days of Week 2 (post-intervention).
Time frame: Week 0, Week 2
Change in high-sensitivity C-reactive protein (hs-CRP) (pg/mL)
Time frame: Week 0, Week 2
Change in Interleukin-6 (IL-6) (pg/mL)
Time frame: Week 0, Week 2
Change in Urine Albumin-Creatinine Ratio (UACR) (mg/g creatinine)
Time frame: Week 0, Week 2
Change in Composite Autonomic Symptom Score-31 (COMPASS-31)
The COMPASS-31 is a 31-item, self-administered clinical questionnaire used to measure the severity and distribution of autonomic nervous system symptoms (dysautonomia). Scores range from 0 to 100, where higher scores indicate worse autonomic dysfunction.
Time frame: Week 0, Week 2
Percentage of participants who achieved ≥85% prescribed minutes (714 of 840 min)
Time frame: Week 2
Percentage of patients that completed ≥70% of scheduled autonomic measurements
Time frame: Week 2
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jan 2028, 14 months later.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 14 months is below that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →