A gentle buzz on the ear: could nerve stimulation soothe the toll of breast cancer?
NCT ID NCT07782866
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This trial tests whether a gentle, non-invasive device called mindvybe can improve wellbeing in people who have had breast cancer. The device delivers mild electrical stimulation near the vagus nerve on the ears and neck, plus specific earlobe points. About 60 adults who finished breast cancer treatment within the past five years and still struggle with low mood, stress, fatigue, or sleep issues will receive five 50-minute sessions over one week. Researchers will track changes in wellbeing, distress, fatigue, sleep, and heart-rate patterns for up to 12 weeks afterward.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Non-invasive transcutaneous electrical stimulation of vagus nerve branches and earlobe acupuncture points via the mindvybe device
- What this could lead to
- If effective, this gentle, drug-free approach could offer a new way to ease mood, stress, fatigue, and sleep problems in breast cancer survivors.
- What could go wrong
- This is a small, open-label study without a placebo group, so results may be influenced by expectation. The device's benefits are unproven and may not be lasting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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46 people
The number who actually took part.
- Started
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Apr 2025
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Redeemer Health
Meadowbrook, Pennsylvania, 19046, United States
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Other studies related to the condition(s) this trial covers.
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