Status:
RECRUITING
Mindfulness in Chronic Kidney Disease
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
This study will test whether mindfulness meditation (MM) improves sympathetic function in chronic kidney disease (CKD) and whether transcutaneous vagus nerve stimulation (tVNS) optimizes the sympatho-...
Detailed Description
Approximately 30 million people in the US have chronic kidney disease (CKD) and are at 5-15 fold greater risk of cardiovascular (CV) disease and mortality. A major factor contributing to increased CV ...
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
Key Trial Info
Start Date :
September 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04099992
Start Date
September 20 2019
End Date
September 1 2026
Last Update
October 21 2025
Active Locations (1)
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1
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30322