MindVybe tVNS/APS for Wellbeing in Breast Cancer Survivors

NCT07782866 | Completed

• 1 other identifier: MindVybe tVNS/APS
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests whether a gentle, non-invasive device called mindvybe can help improve feelings of wellbeing in people who have had breast cancer. Mindvybe delivers mild electrical stimulation near the vagus nerve (on the ears and neck) and to specific points on the earlobes. About 60 adults (ages 18-75) who finished breast cancer treatment within the past five years and still have ongoing wellbeing problems (such as low mood, stress, fatigue, or sleep issues) will take part. Participants will receive five 50-minute mindvybe sessions over one week. Researchers will measure changes in wellbeing, distress, fatigue, sleep, and heart-rate patterns before, during, and for up to 12 weeks after the sessions. The study is open-label (everyone receives the same treatment) and is considered low-risk.

Conditions

Breast Cancer

Keywords

mindvybe, transcutaneous vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Change in Psychological General Well-Being Index - Short Form (PGWB-S) Score

  The PGWB-S is an 18-item self-report questionnaire that measures subjective psychological well-being and distress. Total scores range from 0 to 110, with higher scores indicating better well-being. The primary outcome is the change (improvement) in PGWB-S score from baseline (before the first session) to after the fifth session, and at follow-up time points.

  Baseline, after the fifth session (Day 7), and at 2, 4, 8, and 12 weeks after the final session

Secondary Outcomes (5)

• Change in WHO-5 Well-Being Index Score

  Baseline, after the fifth session (Day 7), and at 2, 4, 8, and 12 weeks after the final session

• Change in NCCN Distress Thermometer Score

  Baseline, after the fifth session (Day 7), and at 2, 4, 8, and 12 weeks after the final session

• Change in PROMIS Fatigue Short Form Score

  Baseline, after the fifth session (Day 7), and at 2, 4, 8, and 12 weeks after the final session

• Change in Insomnia Severity Index (ISI) Score

  Baseline, after the fifth session (Day 7), and at 2, 4, 8, and 12 weeks after the final session

• Change in Heart Rate Variability (HRV)

  Baseline (before first session) and after the fifth session (Day 7)

Study Arms (1)

mindvybe tVNS/APS

EXPERIMENTAL

Participants receive five 50-minute sessions of mindvybe™ over a 7-day period. mindvybe™ is a non-invasive device that delivers ultra-low-current electrical stimulation to the skin near the auricular and cervical branches of the vagus nerve and to acupuncture points on both earlobes.

Device: Transcutaneous vagus nerve and acupuncture point stimulation

Interventions

Transcutaneous vagus nerve and acupuncture point stimulation DEVICE

Non-invasive transcutaneous stimulation delivered to the skin near the auricular and cervical branches of the vagus nerve and to acupuncture points on both earlobes using ultra-low electrical current. Participants receive five 50-minute sessions over a 7-day period.

mindvybe tVNS/APS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• The Healing Consciousness Foundation: lead

Study Sites (1)

Redeemer Health

Meadowbrook, Pennsylvania, 19046, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: April 14, 2025
• Primary Completion: July 24, 2026
• Study Completion: July 24, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)