RECRUITING

Mindfulness in Chronic Kidney Disease

Talk to us

Conditions

Chronic Kidney DiseasesMindfulnessTranscutaneous Vagus Nerve StimulationtVNSSympatho-inhibitory effects

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)

Quick Facts

Study Start:2019-09-20
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04099992

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * stages III and IV CKD as defined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation
  2. * stable renal function (no greater than a decline of eGFR of 1 cc/min/1.73 m2 per month over the prior 3 months)
  1. * severe CKD (eGFR\<15 cc/min)
  2. * diabetic neuropathy
  3. * autonomic dysfunction
  4. * any serious disease that might influence survival
  5. * anemia with hemoglobin \<10 g/dL
  6. * treatment with central α-agonists or monoamine oxidase (MAO) inhibitors
  7. * myocardial infarction or cerebrovascular accident within the past 6 months
  8. * uncontrolled hypertension (BP≥170/100 mm Hg)
  9. * low BP (BP\<100/50 mm Hg)
  10. * bradycardia (HR\<55 beats/min)
  11. * ongoing drug or alcohol abuse (defined as \>2 drinks/day in men, and \>1 drink/day in women)
  12. * surgery within the past 3 months
  13. * adjustment of antihypertensive medications within the past month
  14. * pregnancy or plans to become pregnant
  15. * psychosis
  16. * suicidal ideation
  17. * implanted electronic or metallic device such as a pacemaker
  18. * implanted hearing aid, bone plate, carotid stent, bone screw at or near the neck
  19. * carotid atherosclerosis
  20. * concurrent use of another stimulating device such as a transcutaneous electrical nerve stimulation (TENS) unit.

Contacts and Locations

Study Contact

Jeanie Park, MD
CONTACT
404-727-2525
jeanie.park@emory.edu
Dana DaCosta
CONTACT
404-727-7762
drdacos@emory.edu

Principal Investigator

Jeanie Park
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Atlanta VA Medical Center
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Jeanie Park, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-20
Study Completion Date2025-08

Study Record Updates

Study Start Date2019-09-20
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Mindfulness
  • Transcutaneous Vagus Nerve Stimulation
  • tVNS
  • Sympatho-inhibitory effects

Additional Relevant MeSH Terms

  • Chronic Kidney Diseases