Effects of Mindfulness on Atrial Fibrillation

March 27, 2018 updated by: Pouria Alipour, Newmarket Electrophysiology Research Group Inc

Effects of Monitored Mindfulness Training on Quality-of-life, Anxiety, and Depression in Patients Awaiting Ablation of Atrial Fibrillation

This study aims to investigate the effect of MUSE (R) Headbands on patients with Atrial Fibrillation who is awaiting pulmonary vein isolation ablation procedure. Patients are randomized in 2 arms. The control arm will not be receiving the MUSE headband, whereas the treatment group obtains a device.

Patients from both group will fill out a quality-of-life questionnaire at the time of enrollment and 3 months post PVI. Results from both arms will be evaluated and ultimately the effect of mindfulness using the headband will be evaluated in the aforementioned patient population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Background:

Atrial fibrillation is the most common arrhythmic disorder and ablation of AF has become an important part of AF treatment. AF is associated with a large number of somatic symptoms like chest pain, fatigue, lightheadedness, palpitations, physical limitations, shortness of breath, irregular rhythm and heart rate but also with psychological comorbidities such as anxiety and depression [1]. In recent years, the severity of these comorbidities has become more apparent in AF patients. For instance, Sears and colleagues found a positive correlation between the number of AF symptoms reported and the number of negative emotions experienced [2]. Since there is prospective data on the effects of AF ablation on long term mortality and morbidity, reduction of AF related symptoms and improvement of quality of life (QoL) is still a major goal of AF ablation [3,4].

Mindful meditation (MM) is a basic form of meditation that involves focusing on one thing internally or externally. Being fully present in the moment is the goal of MM. Practicing MM teaches relaxation and concentration on experiencing bodily sensations such as breathing patterns. Mindfulness is independent of environmental stimuli; it is a state of mind that can be achieved at any time [5]. Studies show that, with practice, this form of meditation can provide both long- and short-term positive effects with respect to reduction in anxiety and depression[6,7]. Immediate and transferable benefits for AF patients include self-regulated attention, heightened perception of internal states, reduced stress and anxiety symptoms, and increased overall well-being.

Mindfulness training can heighten meta-cognitive processing, which can improve a person's ability to control adverse thoughts and feelings. Consistent mindful meditation training can induce neuroplasticity[7,8].

The amygdala is a crucial brain structure that is hyperactive during perceived stressful conditions [8]. Being able to utilize skills to control emotions in stressful situations will be beneficial in controlling psychological hyperactivity. Studies show after mindful-attention training there is a decrease in amygdala activity even when in a non-meditative state [6]. This is proof that skills obtained during meditation have lasting positive neural effects. In another study, Holzel et al. found that after eight weeks of MM training, there was a significant correlation between a decrease in subjective stress and a decrease in amygdala's gray matter density. Therefore, a reduction in stress output is positively correlated with gray matter density. MM training induces brain changes in the amygdala and resting state connectivity, which have impacts on cognition such as an increase in attentional control and executive function [9].

Neurofeedback training (NFT) is a method where participants are hooked up to an EEG which allows participants to see how active their brain is and monitor neural changes in real-time. NFT is proven to significantly enhance the positive effects of MM training and have a positive effect on depression[10,11].

The present study is going to investigate the psychological and physiological benefits of mindful meditation (MM) training in patients with atrial fibrillation (AF) using a system for real-time-neurofeedback.

Rationale for study design:

Although there is growing evidence that there might also positive prognostic effects especially on stroke risk [12,13] treatment of AF related symptoms is still one of the major targets of AF ablation. Lakkireddy and colleagues showed that yoga could improve symptoms and QoL as well as anxiety and depression scores [14] in AF patients, illustrating that alternative therapy can be highly effective in AF and be a valuable addition to somatic therapy like AF-ablation.

In this study investigators want to investigate the effects of mindfulness meditation that is supported by the MUSE™ headband which is a device that provides neurofeedback during the meditation. This way investigators seek not only to improve the effects of the meditation but also will be able to monitor therapy compliance via the implemented software.

Since patients with AF are a very heterogeneous group and AF burden, comorbidities as well as symptom perception can differ significantly investigators chose to investigate the less diverse group of patients with symptomatic AF that are scheduled for AF ablation. By applying prospective randomization investigators avoid the risk of a significant bias in baseline patient characteristics and comorbidities.

Study design and aims:

A total number of 60 patients waiting for an AF ablation for symptomatic AF will be included into this prospective, randomized pilot study. All patients will undergo assessment of QoL, anxiety and depression using 3 self-reporting scales for QoL, anxiety and depression at baseline and after 12 weeks. The scales are listed in Appendix A.

At baseline patients will be 1:1 randomized to be either part of the intervention (Group 1) or control (Group 2) group. Patients in Group 1 will be supplied with the MUSE™ headband (InteraXon Inc., Toronto, Canada) that is a tool for mindfulness meditation with neurofeedback. Patients in Group 2 will not undergo any study-related treatment.

The aim of this study will be to investigate the effects of mindfulness meditation with neurofeedback on QoL, anxiety and depression in patients awaiting AF ablation. The results of the study will also be the basis of future studies further investigating the

Statistical analysis:

The primary endpoint will be expressed as mean or median test result where applicable. The secondary endpoint will be measured by the individual duration of use of the device in group 1. The Shapiro-Wilks-test will be used to test for normality of distribution and the Mann-Whitney-U test will be applied for comparison of means.

Study-timeline and Budget:

Our institution is a high volume centre for AF ablations that performs 300-350 procedures per year. Because of the non-invasive character of the MUSE-device investigators expect a high recruitment rate and plan to complete enrollment of the 60 patients within 6 months. With a follow-time of 3 months investigators expect to complete patient inclusion and follow-up after 9 months. Data analysis will take approximately 4 weeks resulting in a total study duration of 10 months.

InteraXon Inc. will provide 30 MUSE™ headbands for the study time.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9

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.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18
  • symptomatic persistent or paroxysmal AF awaiting ablation of AF

Exclusion Criteria:

  • Known Anxiety and Depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
These patients will not receive a device, but have to fill out a quality of life questionnaire at the time of enrollment and 3 months after their procedure.
Experimental: Treatment Group
These patients will receive the device. they are expected to use it for at least 5 minutes per day. Patients in this arm will fill out a quality of life questionnaire at the time of enrollment and 3 months after their procedure.
Device: MUSE Headband
MUSE Headband will help patients with mindfulness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: 12 weeks
patients in both arms will fill out a questionnaire for QoL 12 weeks after their ablation.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newmarket Electrophysiology Research Group Inc

Investigators

  • Study Director: Atul Verma, MD, Newmarket Electrophysiology Research Group

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 Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NERG-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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