Mindfulness in Chronic Kidney Disease

Not Applicable

Recruiting

Conditions: Chronic Kidney Diseases

Interventions: Behavioral: Mindfulness-based stress reduction (MBSR)
Behavioral: Health enhancement program (HEP)
Device: Transcutaneous Vagus Nerve Stimulation (tVNS)
Device: Sham-transcutaneous Vagus Nerve Stimulation (tVNS)

Registration Number: NCT04099992

Lead Sponsor: Emory University

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.

Recruitment & Eligibility

Status: RECRUITING

Sex: All

Target Recruitment: 150

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 Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Stress Reduction (MBSR)	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.
MBSR+tVNS	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+tVNS	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. 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)	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.
HEP+tVNS	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	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. 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.
HEP+sham-tVNS	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.
MBSR+sham-tVNS	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.
MBSR+sham-tVNS	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. 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	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 (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).

Primary Outcome Measures

Name	Time	Method
Change in mean Muscle Sympathetic Nerve Activity (MSNA) burst frequency (BF)	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 (BF, bursts/min).

Secondary Outcome Measures

Name	Time	Method
Change in daytime burst frequency (BF)	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 (BF, bursts/min).
Change in Tumor necrosis factor (TNF) level	Baseline, 8 weeks	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.
Change in nocturnal dipping of burst frequency (BF)	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 (BF, bursts/min).
Change in baroreflex sensitivity (BRS)	Baseline, 8 weeks	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.

Trial Locations

Locations (1): Atlanta VA Medical Center
🇺🇸
Atlanta, Georgia, United States

Mindfulness in Chronic Kidney Disease

Recruitment & Eligibility

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