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COMPLETED
NCT07782866
NA

MindVybe tVNS/APS for Wellbeing in Breast Cancer Survivors

Sponsor: The Healing Consciousness Foundation

View on ClinicalTrials.gov

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.

Official title: An Open Label Study of Non-invasive Stimulation of Right and Left Auricular and Cervical Branches of the Vagus Nerve and Acupuncture Points Located on Both Earlobes Via Mindvybe Aimed at Improving Well- Being Disturbances Associated With Breast Cancer and Its Treatment

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2025-04-14

Completion Date

2026-07-24

Last Updated

2026-08-24

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Transcutaneous vagus nerve and acupuncture point stimulation

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.

Locations (1)

Redeemer Health

Meadowbrook, Pennsylvania, United States