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Mindfulness in Chronic Kidney Disease

Mindfulness in Chronic Kidney Disease

Recruiting
40-80 years
All
Phase N/A

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Overview

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-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients.

Description

~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 risk in these patients is chronic elevation of sympathetic nervous system (SNS) activity. New therapeutic strategies to safely and effectively ameliorate SNS over-activity are of paramount importance to improve clinical outcomes in this highly prevalent and high-risk patient population.

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-inhibitory effects of mindfulness meditation (MM) and restores autonomic balance in CKD patients.

Eligibility

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.

Study details
    Chronic Kidney Diseases

NCT04099992

Emory University

27 January 2024

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