BridgeMD
New treatment option for Chronic Kidney Diseases
Official title Mindfulness in Chronic Kidney Disease
ClinicalTrials.gov ID: NCT04099992
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.