Breast CancerNCT07782866
MindVybe tVNS/APS for Wellbeing in Breast Cancer Survivors
A study testing Transcutaneous vagus nerve and acupuncture point stimulation in people with Breast Cancer, run by The Healing Consciousness Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Transcutaneous vagus nerve and acupuncture point stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to 24 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Transcutaneous vagus nerve and acupuncture point stimulation
- Keywords
- mindvybe, transcutaneous vagus nerve stimulation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous vagus nerve and acupuncture point stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous vagus nerve and acupuncture point stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The WHO-5 is a 5-item self-report scale measuring subjective psychological well-being. Scores range from 0 to 100, with higher scores indicating better well-being.
Measured: 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
The NCCN Distress Thermometer is a single-item self-report tool that measures distress on a 0-10 scale (0 = no distress, 10 = extreme distress).
Measured: 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
The PROMIS Fatigue Short Form assesses the impact of fatigue on daily functioning and overall well-being. Higher scores indicate greater fatigue.
Measured: 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
The Morin Insomnia Severity Index is a 7-item self-report questionnaire assessing the severity and impact of insomnia. Higher scores indicate more severe insomnia.
Measured: 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)
Heart Rate Variability measured using the NeuralChek system as an objective indicator of autonomic nervous system balance.
Measured: Baseline (before first session) and after the fifth session (Day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start14 Apr 2025
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Healing Consciousness Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782866
- Sponsor's protocol ID
- MindVybe tVNS/APS
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07782866
- Acronym / sponsor ID
- MindVybe tVNS/APS
- Conditions
- Breast Cancer
- Keywords
- mindvybe, transcutaneous vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- The Healing Consciousness FoundationUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mindvybe tVNS/APS | Experimental | Device: Transcutaneous vagus nerve and acupuncture point stimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous vagus nerve and acupuncture point stimulationNon-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. | Device | mindvybe tVNS/APS |
Primary outcome
Change in Psychological General Well-Being Index - Short Form (PGWB-S) Score
Time frame: Baseline, after the fifth session (Day 7), and at 2, 4, 8, and 12 weeks after the final session
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.
5 secondary outcomes
Change in WHO-5 Well-Being Index Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline (before first session) and after the fifth session (Day 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous vagus nerve and acupuncture point stimulation in people with Breast Cancer, run by The Healing Consciousness Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psychological General Well-Being Index - Short Form (PGWB-S) Score (time frame: Baseline, after the fifth session (Day 7), and at 2, 4, 8, and 12 weeks after the final session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.