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Mindfulness in Chronic Kidney Disease (MIND-CKD)

Primary Purpose

Chronic Kidney Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-based stress reduction (MBSR)
Health enhancement program (HEP)
Transcutaneous Vagus Nerve Stimulation (tVNS)
Sham-transcutaneous Vagus Nerve Stimulation (tVNS)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Mindfulness, Transcutaneous Vagus Nerve Stimulation, tVNS, Sympatho-inhibitory effects

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atlanta VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Mindfulness-Based Stress Reduction (MBSR)

Health enhancement program (HEP)

MBSR+tVNS

MBSR+sham-tVNS

HEP+tVNS

HEP+sham-tVNS

Arm Description

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) 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.

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) .

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.

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).

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.

Outcomes

Primary Outcome Measures

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 (BF, bursts/min).

Secondary Outcome Measures

Change in daytime 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 (BF, bursts/min).
Change in nocturnal dipping of 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 (BF, bursts/min).
Change in baroreflex sensitivity (BRS)
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.
Change in Tumor necrosis factor (TNF) level
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.

Full Information

First Posted
September 20, 2019
Last Updated
September 8, 2023
Sponsor
Emory University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04099992
Brief Title
Mindfulness in Chronic Kidney Disease
Acronym
MIND-CKD
Official Title
Sympatho-inhibition With Mindfulness in Chronic Kidney Disease (MIND-CKD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2019 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
~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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Mindfulness, Transcutaneous Vagus Nerve Stimulation, tVNS, Sympatho-inhibitory effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Protocol 1 (R61): 50 CKD participants will be randomized to MBSR (N=25) versus an active control intervention (health enhancement program, HEP; N=25). Protocol 2 (R33): 75 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
ParticipantInvestigatorOutcomes Assessor
Masking Description
A third-party investigator outside of the research team will label both real and sham devices with a coded number so that both participants and investigators can remain double-masked during the clinical trial.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Stress Reduction (MBSR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Health enhancement program (HEP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MBSR+tVNS
Arm Type
Experimental
Arm Description
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) .
Arm Title
MBSR+sham-tVNS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HEP+tVNS
Arm Type
Experimental
Arm Description
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).
Arm Title
HEP+sham-tVNS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction (MBSR)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health enhancement program (HEP)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcutaneous Vagus Nerve Stimulation (tVNS)
Intervention Description
Transcutaneous Vagus Nerve Stimulation (tVNS) is delivered using gammaCore (Electrocore), 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.
Intervention Type
Device
Intervention Name(s)
Sham-transcutaneous Vagus Nerve Stimulation (tVNS)
Intervention Description
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 Information:
Title
Change in mean Muscle Sympathetic Nerve Activity (MSNA) burst frequency (BF)
Description
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 (BF, bursts/min).
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in daytime burst frequency (BF)
Description
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 (BF, bursts/min).
Time Frame
Baseline, 8 weeks
Title
Change in nocturnal dipping of burst frequency (BF)
Description
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 (BF, bursts/min).
Time Frame
Baseline, 8 weeks
Title
Change in baroreflex sensitivity (BRS)
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change in Tumor necrosis factor (TNF) level
Description
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.
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanie Park, MD
Phone
404-727-2525
Email
jeanie.park@emory.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dana DaCosta
Phone
404-727-7762
Email
drdacos@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanie Park
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta VA Medical Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanie Park, MD
Phone
404-727-2525
Email
jeanie.park@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in the article after deidentification (text, tables, figures, and appendices) will be available for sharing.
IPD Sharing Time Frame
Data will be available for sharing beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal for individual participant data meta-analyses and whose proposed use of the data has been approved by an independent review committee identified for this purpose. Requests should be directed to Jeanie.park@emory.edu.

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Mindfulness in Chronic Kidney Disease

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