MindVybe tVNS/APS for Wellbeing in Breast Cancer Survivors

This is an open-label study evaluating the effects of mindvybe™, a general wellness device that delivers non-invasive, ultra-low-current transcutaneous stimulation near the auricular and cervical branches of the vagus nerve, combined with stimulation of specific acupuncture points on both earlobes (tVNS/APS). The study focuses on adults who experience wellbeing disturbances related to breast cancer and its treatment.

Background Breast cancer and its treatments can significantly impair psychological wellbeing, including mood, stress levels, fatigue, and sleep quality. Prior research and real-world use of mindvybe™ have shown that short sessions of this dual-mode stimulation can improve subjective wellbeing measures with a favorable safety profile. This study aims to systematically assess whether a structured course of mindvybe™ sessions can enhance wellbeing in this population and to evaluate the duration of any benefits.

Study Design Approximately 60 adults aged 18-75 years who have completed primary breast cancer treatment (chemotherapy and/or radiotherapy) within the past five years, or who are receiving ongoing chronic treatment for stage IV disease, will be enrolled. Participants must self-identify as having wellbeing disturbances and meet inclusion criteria based on the Office for National Statistics Four subjective well-being questions (ONS4).

Participants will be stratified into two groups at baseline:

Group A: higher wellbeing scores on ONS4 Group B: lower wellbeing scores on ONS4

All participants will receive the same intervention: five daily 50-minute mindvybe™ sessions administered over a 7-day period at a single clinical site. Sessions involve placement of electrodes on the neck (cervical branch), outer ear (auricular branch/cymba concha), and earlobes (acupuncture points). The device uses proprietary closed-loop ultra-low-current waveforms designed for comfort and to minimize risk of overstimulation.

Assessments

Validated self-report scales and an objective biometric measure will be collected:

Primary outcome: Psychological General Well-Being Index - Short Form (PGWB-S) Secondary outcomes: WHO-5 Well-Being Index, NCCN Distress Thermometer, PROMIS Fatigue Short Form, Morin Insomnia Severity Index, and NeuralChek Heart Rate Variability (HRV)

Assessments occur at baseline, before/after selected sessions, and at follow-up visits approximately 2, 4, 8, and 12 weeks after the final session. Follow-up visits may be completed in person or via video conference.

Safety mindvybe™ is classified as a general wellness product and the study is considered non-significant risk. Participants will be monitored for adverse events before, during, and after sessions and throughout the 12-week follow-up period. Any adverse events will be reviewed by a Safety Monitoring Board.

Objectives The primary goals are to determine whether mindvybe™ sessions improve subjective wellbeing (mood, fatigue, sleep, and distress) in people with breast cancer-related wellbeing disturbances, to assess short-term safety and tolerability, and to evaluate the duration of any observed benefits over 12 weeks.

Inclusion criteria

Age 18 to 75 years Diagnosis of breast cancer with treatment completed within the past 5 years (chemotherapy and/or radiotherapy finished), or currently receiving chronic treatment for stage IV breast cancer Self-reported wellbeing disturbances related to breast cancer or its treatment Score of 6 or less on the life satisfaction, worthwhile, and/or happiness questions of the Office for National Statistics Four subjective well-being questions (ONS4) Able and willing to provide informed consent Able to attend five in-person sessions over a 7-day period and complete follow-up assessments -

Exclusion criteria

Age less than 18 years or greater than 75 years Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure) History of abnormal ECG (e.g., second- or third-degree heart block, atrial fibrillation, atrial flutter, recent ventricular tachycardia or fibrillation, or clinically significant premature ventricular contractions) Uncontrolled high blood pressure Known or suspected cerebrovascular disease Previous cervical vagotomy Current implantation of any electrical or neurostimulator device (including cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal cord stimulator, or cochlear implant) Metallic implant near the stimulation sites Pregnant, planning to become pregnant during the study period, or of childbearing potential and unwilling to use an accepted form of contraception Unable or unwilling to provide informed consent or comply with study procedures

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