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Mindfulness and Vagus Nerve Stimulation for Chronic Kidney Disease

This study is exploring whether mindfulness-based stress reduction (MBSR) and transcutaneous vagus nerve stimulation (tVNS) can improve nerve activity in people with chronic kidney disease (CKD). Researchers want to see if MBSR, which teaches you to be more aware of your thoughts and feelings, can help, and if tVNS, a device that stimulates a nerve, can make these benefits even better. You might be able to join if you are between 40 and 80 years old and have stages III or IV CKD with stable kidney function. The study will measure changes in your muscle sympathetic nerve activity to see if these interventions are successful. The current status of this study is unclear, and it plans to enroll 150 participants.

Study design
This interventional study plans to enroll 150 participants. It compares mindfulness-based stress reduction (MBSR) and a health enhancement program (HEP), as well as transcutaneous vagus nerve stimulation (tVNS) and a sham tVNS device.
What's involved
Participants in the MBSR or HEP groups will attend 8 weekly 2.5-hour sessions and one day-long retreat. Participants using tVNS or sham tVNS will self-administer the device twice daily for 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your muscle sympathetic nerve activity will be measured at the beginning of the study and again at 8 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04099992

Mindfulness in Chronic Kidney Disease

Recruiting
NAAges 40–80InterventionalTreatment
Emory University
~150 participants
Updated 2025-10-21 on ClinicalTrials.gov
What's tested:Mindfulness-based stress reduction (MBSR)Health enhancement program (HEP)Transcutaneous Vagus Nerve Stimulation (tVNS)Sham-transcutaneous Vagus Nerve Stimulation (tVNS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Mean Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency (BF)
Measured over Baseline, 8 weeks

Conditions

Chronic Kidney Diseases

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NCT04099992

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Atlanta VA Medical Center

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jeanie Park · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Jeanie Park, MD
[email protected]
404-727-2525
Email the study team

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Eligibility criteria

Inclusion

stages III and IV CKD as defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
stable renal function (no greater than a decline of eGFR of 1 cc/min/1.73 m2 per month over the prior 3 months)

Exclusion

severe CKD (eGFR\<15 cc/min)
diabetic neuropathy
autonomic dysfunction
any serious disease that might influence survival
anemia with hemoglobin \<10 g/dL
treatment with central α-agonists or monoamine oxidase (MAO) inhibitors
myocardial infarction or cerebrovascular accident within the past 6 months
uncontrolled hypertension (BP≥170/100 mm Hg)
low BP (BP\<100/50 mm Hg)
bradycardia (HR\<55 beats/min)
ongoing drug or alcohol abuse (defined as \>2 drinks/day in men, and \>1 drink/day in women)
surgery within the past 3 months
adjustment of antihypertensive medications within the past month
pregnancy or plans to become pregnant
psychosis
suicidal ideation
implanted electronic or metallic device such as a pacemaker
implanted hearing aid, bone plate, carotid stent, bone screw at or near the neck
carotid atherosclerosis
concurrent use of another stimulating device such as a transcutaneous electrical nerve stimulation (TENS) unit

What this trial measures

  • Change in Mean Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency (BF)Baseline, 8 weeks

    Multiunit postganglionic sympathetic nerve activity is recorded from a tungsten microelectrode inserted into the peroneal nerve with a reference microelectrode inserted in close proximity. Efferent nerve signals are amplified, filtered, rectified and integrated (time constant 0.1 s) to obtain a mean voltage display of MSNA. MSNA bursts are automatically detected using the following criteria: burst-to-noise ratio of 3:1 within a 0.5-s search window, with an average latency of 1.2-1.3 s in burst occurrence from the previous R-wave. MSNA is expressed as burst frequency measured a bursts per minute.