Chronic Kidney DiseasesMIND-CKDNCT04099992
Mindfulness in Chronic Kidney Disease
A study testing Mindfulness-based stress reduction (MBSR), Health enhancement program (HEP) and Transcutaneous Vagus Nerve Stimulation (tVNS) in people with Chronic Kidney Diseases, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Mindfulness-based stress reduction (MBSR), Health enhancement program (HEP) and Transcutaneous Vagus Nerve Stimulation (tVNS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2019to 7 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)
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.
Read the detailed description
Approximately 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.
Patients with even minimal decrements in kidney function have significant and substantial increases in SNS activity and reactivity that are independently linked to adverse CV events. The mechanisms underlying SNS overactivity in CKD are multifactorial, and include chronic inflammation and blunted arterial baroreflex sensitivity (BRS). SNS overactivity, in turn, leads to downstream deleterious effects on ambulatory BP profiles characterized by higher daytime BP, and lack of normal reductions in nocturnal BP (i.e. nocturnal nondipping), both of which are independently linked to increased CV risk. Current treatments to combat SNS overactivity are limited to sympatholytic medications such as β-blockers, α-blockers, and clonidine; however, these pharmacologic agents are associated with long-term adverse metabolic consequences such as insulin resistance and hyperlipidemia, and often intolerable side effects such as fatigue, orthostatic hypotension, and rebound hypertension. 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.
Mindfulness meditation (MM) may be one such novel, safe, and effective approach at improving hemodynamics and autonomic function in CKD. Prior studies have shown that 8 weeks of mindfulness-based stress reduction (MBSR) lowers BP in a variety of patient groups. Although the mechanisms are poorly understood, studies using indirect measures of SNS activity such as heart rate variability suggest that MM may exert its hemodynamic effects via autonomic modulation.
This study tests 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. These study aims are tested with two separate protocols.
Protocol 1 tests the sustained effects of MBSR on SNS function and BP profiles in CKD. Participants will be randomized to 8 weeks of MBSR or a health enhancement program (HEP).
Protocol 2 tests an optimization strategy to enhance the sympatho-inhibitory effects of MM and restore autonomic balance using transcutaneous vagus nerve stimulation (tVNS) in CKD. The vagus nerve, the major effector of the parasympathetic nervous system (PNS), is composed of afferent nerve fibers that connect to the nucleus tractus solitarii (NTS) and other brainstem regions that influence central SNS output and baroreflexes, and efferent nerve fibers that activate the cholinergic anti-inflammatory pathway. Both experimental and human studies have shown promising results that stimulation of the vagus nerve lowers BP reduces SNS activity, improves BRS, and lowers inflammation. Participants with Stage III and IV CKD will be randomized into one of four study arms: MBSR with tVNS, MBSR with sham-tVNS, HEP with tVNS, and HEP with sham-tVNS. Participants will self-administer tVNS or sham-tVNS twice per day for 8 weeks.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Mindfulness-based stress reduction (MBSR), Health enhancement program (HEP), Transcutaneous Vagus Nerve Stimulation (tVNS), Sham-transcutaneous Vagus Nerve Stimulation (tVNS)
- Keywords
- Mindfulness, Transcutaneous Vagus Nerve Stimulation, tVNS, Sympatho-inhibitory effects
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reduction (MBSR)Behavioural
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)Behavioural
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)Device
Also called gammaCore, Electrocore
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | 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. Receives: Behavioral: Mindfulness-based stress reduction (MBSR) |
| Health enhancement program (HEP) | Active comparator | 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. Receives: Behavioral: Health enhancement program (HEP) |
| MBSR+tVNS | Experimental | 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) . Receives: Behavioral: Mindfulness-based stress reduction (MBSR); Device: Transcutaneous Vagus Nerve Stimulation (tVNS) |
| MBSR+sham-tVNS | Active comparator | 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. Receives: Behavioral: Mindfulness-based stress reduction (MBSR); Device: Sham-transcutaneous Vagus Nerve Stimulation (tVNS) |
| HEP+tVNS | Experimental | 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). Receives: Behavioral: Health enhancement program (HEP); Device: Transcutaneous Vagus Nerve Stimulation (tVNS) |
| HEP+sham-tVNS | Active comparator | 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. Receives: Behavioral: Health enhancement program (HEP); Device: Sham-transcutaneous Vagus Nerve Stimulation (tVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency (BF)
Multiunit postganglionic sympathetic nerve activity is recorded from a tungsten microelectrode inserted into the peroneal nerve with a reference microelectrode inserted in close proximity. Efferent nerve signals are amplified, filtered, rectified and integrated (time constant 0.1 s) to obtain a mean voltage display of MSNA. MSNA bursts are automatically detected using the following criteria: burst-to-noise ratio of 3:1 within a 0.5-s search window, with an average latency of 1.2-1.3 s in burst occurrence from the previous R-wave. MSNA is expressed as burst frequency measured as bursts per minute.
Measured: Baseline, 8 weeks
Secondary outcomes (5)
Change in Daytime Blood Pressure (BP)
Blood pressure is assessed with 24-hour ambulatory BP monitoring. Upper arm readings will be taken for at least 24 hours. BP measurements will be made every 20 minutes during the daytime period, from 7 ante meridiem (AM) to 11 post meridiem (PM). Participants will record their wake and sleep times, and analyses will be adjusted for the participant's individual wake and sleep times.
Measured: Baseline, 8 weeks
Change in Nocturnal Dipping of Blood Pressure (BP)
Blood pressure is assessed with 24-hour ambulatory BP monitoring. Upper arm readings will be taken for at least 24 hours. BP measurements will be made every 30 minutes during the nighttime period, from 11 PM to 7 AM. Participants will record their wake and sleep times, and analyses will be adjusted for the participant's individual wake and sleep times.
Measured: Baseline, 8 weeks
Change in Heart Rate Assessed by 24-hour EKG Monitoring
The 24-hour EKG monitoring will be performed using a portable Holter monitor. Stickers will be placed on the participants chest to record their heart rate.
Measured: Baseline, 8 weeks
Change in Baroreflex Sensitivity (BRS) Among Protocol 2 Participants
Afferent sympathetic baroreflex input travels to the brainstem via the glossopharyngeal and vagus nerves and integrate with brainstem centers that regulate efferent SNS (sympathetic BRS) and parasympathetic (cardiovagal BRS) outflow. BRS is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg.
Measured: Baseline, 8 weeks
Change in Tumor Necrosis Factor (TNF) Level Among Protocol 2 Participants
Tumor necrosis factor (TNF) is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. It will be measured by blood test.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start20 Sep 2019
- Primary completion7 May 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Protocol 1 (R61): 50 CKD participants will be randomized to MBSR (N=25) versus an active control intervention (health enhancement program; N=25). Protocol 2 (R33): 100 CKD participants will be randomized to MBSR+tVNS (n=25), MBSR+sham-tVNS (n=25), HEP+tVNS (n=25), and HEP+sham-tVNS (n=25).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jeanie Park, Emory University
- Investigators
- Jeanie Park, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099992
- Sponsor's protocol ID
- IRB00110956
- Other IDs
- 5R61AT010457, 4R33AT010457, 2025P011324
- Acronym
- MIND-CKD
- Status last verified
- Oct 2026
- First submitted
- 20 Sep 2019
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices) will be available for sharing.
Publications
Jeong J, Hu Y, Zanuzzi M, DaCosta D, Sabino-Carvalho JL, Li S, Park J. Autonomic modulation with mindfulness-based stress reduction in chronic kidney disease: a randomized controlled trial. J Physiol. 2025 Jan;603(2):489-505. doi: 10.1113/JP287321. Epub 2024 Dec 18.
PubMed 39693497
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)
- ClinicalTrials.gov ID
- NCT04099992
- Acronym / sponsor ID
- MIND-CKD / IRB00110956
- Conditions
- Chronic Kidney Diseases
- Keywords
- Mindfulness, Transcutaneous Vagus Nerve Stimulation, tVNS, Sympatho-inhibitory effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 7 May 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 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.
Patients with even minimal decrements in kidney function have significant and substantial increases in SNS activity and reactivity that are independently linked to adverse CV events. The mechanisms underlying SNS overactivity in CKD are multifactorial, and include chronic inflammation and blunted arterial baroreflex sensitivity (BRS). SNS overactivity, in turn, leads to downstream deleterious effects on ambulatory BP profiles characterized by higher daytime BP, and lack of normal reductions in nocturnal BP (i.e. nocturnal nondipping), both of which are independently linked to increased CV risk. Current treatments to combat SNS overactivity are limited to sympatholytic medications such as β-blockers, α-blockers, and clonidine; however, these pharmacologic agents are associated with long-term adverse metabolic consequences such as insulin resistance and hyperlipidemia, and often intolerable side effects such as fatigue, orthostatic hypotension, and rebound hypertension. 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.
Mindfulness meditation (MM) may be one such novel, safe, and effective approach at improving hemodynamics and autonomic function in CKD. Prior studies have shown that 8 weeks of mindfulness-based stress reduction (MBSR) lowers BP in a variety of patient groups. Although the mechanisms are poorly understood, studies using indirect measures of SNS activity such as heart rate variability suggest that MM may exert its hemodynamic effects via autonomic modulation.
This study tests 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. These study aims are tested with two separate protocols.
Protocol 1 tests the sustained effects of MBSR on SNS function and BP profiles in CKD. Participants will be randomized to 8 weeks of MBSR or a health enhancement program (HEP).
Protocol 2 tests an optimization strategy to enhance the sympatho-inhibitory effects of MM and restore autonomic balance using transcutaneous vagus nerve stimulation (tVNS) in CKD. The vagus nerve, the major effector of the parasympathetic nervous system (PNS), is composed of afferent nerve fibers that connect to the nucleus tractus solitarii (NTS) and other brainstem regions that influence central SNS output and baroreflexes, and efferent nerve fibers that activate the cholinergic anti-inflammatory pathway. Both experimental and human studies have shown promising results that stimulation of the vagus nerve lowers BP reduces SNS activity, improves BRS, and lowers inflammation. Participants with Stage III and IV CKD will be randomized into one of four study arms: MBSR with tVNS, MBSR with sham-tVNS, HEP with tVNS, and HEP with sham-tVNS. Participants will self-administer tVNS or sham-tVNS twice per day for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Protocol 1 (R61): 50 CKD participants will be randomized to MBSR (N=25) versus an active control intervention (health enhancement program; N=25). Protocol 2 (R33): 100 CKD participants will be randomized to MBSR+tVNS (n=25), MBSR+sham-tVNS (n=25), HEP+tVNS (n=25), and HEP+sham-tVNS (n=25).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR) | Experimental | Behavioral: 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. |
| Health enhancement program (HEP) | Active comparator | Behavioral: 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. |
| MBSR+tVNS | Experimental | Behavioral: Mindfulness-based stress reduction (MBSR), Device: Transcutaneous Vagus Nerve Stimulation (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) . |
| MBSR+sham-tVNS | Active comparator | Behavioral: Mindfulness-based stress reduction (MBSR), Device: Sham-transcutaneous Vagus Nerve Stimulation (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. |
| HEP+tVNS | Experimental | Behavioral: Health enhancement program (HEP), Device: Transcutaneous Vagus Nerve Stimulation (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). |
| HEP+sham-tVNS | Active comparator | Behavioral: Health enhancement program (HEP), Device: Sham-transcutaneous Vagus Nerve Stimulation (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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (20 listed)
- severe CKD (eGFR<15 cc/min)
- diabetic neuropathy
- autonomic dysfunction
- any serious disease that might influence survival
- anemia with hemoglobin <10 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | MBSR+sham-tVNS, MBSR+tVNS, Mindfulness-Based Stress Reduction (MBSR) |
| 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. | Behavioural | HEP+sham-tVNS, HEP+tVNS, Health enhancement program (HEP) |
| Transcutaneous Vagus Nerve Stimulation (tVNS)Also: gammaCore, ElectrocoreParticipants 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. | Device | HEP+tVNS, MBSR+tVNS |
| 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. | Device | HEP+sham-tVNS, MBSR+sham-tVNS |
Primary outcome
Change in Mean Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency (BF)
Time frame: Baseline, 8 weeks
Multiunit postganglionic sympathetic nerve activity is recorded from a tungsten microelectrode inserted into the peroneal nerve with a reference microelectrode inserted in close proximity. Efferent nerve signals are amplified, filtered, rectified and integrated (time constant 0.1 s) to obtain a mean voltage display of MSNA. MSNA bursts are automatically detected using the following criteria: burst-to-noise ratio of 3:1 within a 0.5-s search window, with an average latency of 1.2-1.3 s in burst occurrence from the previous R-wave. MSNA is expressed as burst frequency measured as bursts per minute.
5 secondary outcomes
Change in Daytime Blood Pressure (BP)
Time frame: Baseline, 8 weeks
Change in Nocturnal Dipping of Blood Pressure (BP)
Time frame: Baseline, 8 weeks
Change in Heart Rate Assessed by 24-hour EKG Monitoring
Time frame: Baseline, 8 weeks
Change in Baroreflex Sensitivity (BRS) Among Protocol 2 Participants
Time frame: Baseline, 8 weeks
Change in Tumor Necrosis Factor (TNF) Level Among Protocol 2 Participants
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 39693497Jeong J, Hu Y, Zanuzzi M, DaCosta D, Sabino-Carvalho JL, Li S, Park J. Autonomic modulation with mindfulness-based stress reduction in chronic kidney disease: a randomized controlled trial. J Physiol. 2025 Jan;603(2):489-505. doi: 10.1113/JP287321. Epub 2024 Dec 18.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices) will be available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanie Park principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction (MBSR), Health enhancement program (HEP) and Transcutaneous Vagus Nerve Stimulation (tVNS) in people with Chronic Kidney Diseases, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Muscle Sympathetic Nerve Activity (MSNA) Burst Frequency (BF) (time frame: Baseline, 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.