Mindfulness meditation and vagus nerve stimulation for chronic kidney disease
Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)
NA · Emory University · NCT04099992
This study is testing if mindfulness meditation and a special nerve stimulation can help people with chronic kidney disease feel better and improve their heart health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Emory University (other) |
| Locations | 1 site (Atlanta, Georgia) |
| Trial ID | NCT04099992 on ClinicalTrials.gov |
What this trial studies
This study investigates whether mindfulness meditation can improve sympathetic nervous system function in patients with chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) enhances these effects. With approximately 30 million people in the US affected by CKD, the study aims to address the chronic elevation of sympathetic nervous system activity that contributes to cardiovascular risks in these patients. Participants will engage in mindfulness-based stress reduction and receive either active or sham tVNS to evaluate the impact on autonomic balance and cardiovascular health.
Who should consider this trial
Good fit: Ideal candidates are individuals with stages III and IV chronic kidney disease who have stable renal function.
Not a fit: Patients with severe chronic kidney disease, autonomic dysfunction, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological method to reduce cardiovascular risks associated with chronic kidney disease.
How similar studies have performed: While mindfulness and vagus nerve stimulation have been explored separately, this combined approach is relatively novel and has not been extensively tested in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Atlanta, Georgia
- Atlanta VA Medical Center — Atlanta, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Jeanie Park — Emory University
- Study coordinator: Jeanie Park, MD
- Email: jeanie.park@emory.edu
- Phone: 404-727-2525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Kidney Diseases, Mindfulness, Transcutaneous Vagus Nerve Stimulation, tVNS, Sympatho-inhibitory effects