Recruiting

Mindfulness

Sponsor:

Emory University

Code:

NCT04099992

Conditions

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Mindfulness-based stress reduction (MBSR)

Health enhancement program (HEP)

Transcutaneous Vagus Nerve Stimulation (tVNS)

Sham-transcutaneous Vagus Nerve Stimulation (tVNS)

Study Details

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

Conditions

Chronic Kidney Diseases

Study ID

NCT04099992

Start date

Sep 20, 2019

Status verified date

Oct, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness-Based Stress Reduction (MBSR)

Mindfulness-Based Stress Reduction (MBSR) tis designed to provide education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. MBSR is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session.

active comparator: Health enhancement program (HEP)

Health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP participants will meet with a health educator in a group setting for 8 weekly 2.5-hour sessions with a day-long retreat.

experimental: MBSR+tVNS

Mindfulness-Based Stress Reduction (MBSR) tis designed to provide education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. MBSR is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session.

Transcutaneous vagus nerve stimulation (tVNS) is a simple, noninvasive, self-administered adjunctive therapy, that may enhance the sympatho-inhibitory effects of mindfulness meditation (MM) in chronic kidney disease (CKD) .

active comparator: MBSR+sham-tVNS

Mindfulness-Based Stress Reduction (MBSR) tis designed to provide education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. MBSR is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session.

Sham stimulation will be delivered using a sham device that is identical in appearance and function to tVNS, but programmed to produce a lower frequency biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.

experimental: HEP+tVNS

Health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP participants will meet with a health educator (a registered dietician) in a group setting for 8 weekly 2.5-hour sessions.

Transcutaneous vagus nerve stimulation (tVNS) is a simple, noninvasive, self-administered adjunctive therapy, that may enhance the sympatho-inhibitory effects of mindfulness meditation (MM) in chronic kidney disease (CKD).

active comparator: HEP+sham-tVNS

Health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP participants will meet with a health educator in a group setting for 8 weekly 2.5-hour sessions.

Sham stimulation is be delivered using a sham device that is identical in appearance and function to tVNS, but programmed to produce a lower frequency (0.1 Hz) biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.

Interventions

Mindfulness-based stress reduction (MBSR)

Mindfulness-based stress reduction (MBSR) is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session. MBSR teaches to become more aware of thoughts, feelings, and sensations, and to skillfully respond to stressors. Each of the sessions includes education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. Participants learn formal mindfulness practices (e.g., meditation, yoga, body scan, body scan) as well as informal such as awareness of breath, thoughts, or emotions, and mindfulness of daily activities. Participants will receive digital audio (MP3) downloads with guided MM practices, a home practice manual, and handouts with each week's assignments. Daily home practice will consist of 40-45 minutes of recorded practice. Participants will log their daily practice. If a participant misses a class, it is possible to make up the class on a different day.

Health enhancement program (HEP)

8-week health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP matches MBSR in structure and content, and in parallel to MBSR, consists of music therapy, nutritional education, posture and balance movements, walking and stretching. Work with all practices with group discussion and exercises during an all-day "spa day" will match the all-day retreat in MBSR. HEP participants will meet with a health educator in a group setting for 8 weekly 2.5-hour sessions. Participants will receive MP3 downloads on an MP3 player with recordings of health education topics, a home listening manual, and weekly handouts with each week's listening assignments. Participants will listen to these MP3 recordings daily for 40-45 minutes and log their daily adherence.

Transcutaneous Vagus Nerve Stimulation (tVNS)

Participants self-administer tVNS twice per day for 8 weeks. tVNS is delivered using a multi-use, hand-held, rechargeable portable device consisting of a rechargeable battery, signal generating and amplifying electronics, and a button for operator control of the stimulation intensity. Conductive gel is applied to the stainless steel round discs on the device and placed vertically on the skin overlying the vagus nerve under the angle of the mandible, between the trachea and sternocleidomastoid muscle. A low-voltage electrical signal is delivered consisting of 5-kilohertz (kHz) sine wave series for 1 ms and repeated every 40 ms, with a maximum delivery of 24 V and 60 milliampere (mA) output. Stimulation amplitude is adjusted by the user and is increased until there is a vibration and slight muscle contraction in the lower face or neck. Stimulation is delivered for 2 minutes on the left side of the neck, and 2 minutes on the right side of the neck, for a total 4 minutes per one dose.

Sham-transcutaneous Vagus Nerve Stimulation (tVNS)

Participants self-administer sham-tVNS twice per day for 8 weeks. Sham stimulation will be delivered using a sham device that is identical in appearance and function, but programmed to produce a lower frequency biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.

Primary outcome measure

  • Change in Mean Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency (BF) [ Time Frame: Baseline, 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

Atlanta VA Medical Center

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

More Information

Sponsor

Emory University

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-10-21.