Mindfulness in Chronic Kidney Disease
Recruiting · NCT04099992 · Interventional (participants receive a specific treatment) · Lead sponsor: Emory University
View the official record on ClinicalTrials.gov →Interventions studied
Health enhancement program (HEP)Mindfulness-based stress reduction (MBSR)Sham-transcutaneous Vagus Nerve Stimulation (tVNS)Transcutaneous Vagus Nerve Stimulation (tVNS)
What this trial is about
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.
Who can take part
Age range
40 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Atlanta VA Medical Center - Atlanta, Georgia, United States