Breast CarcinomaEarly Phase 1NCT06274034
MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors
A Early Phase 1 study testing Electronic Health Record Review, Medical Device Usage and Evaluation and Meditation Therapy in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Electronic Health Record Review, Medical Device Usage and Evaluation and Meditation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 3 Oct 2025
- Phase
- Early Phase 1
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-80
- Breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years
- Patients report experiencing anxiety and insomnia both rated > 3 on a 0-10 scale (with 0 indicating none) at the time of enrollment
- Patients on anti-anxiety/anti-depressant medication must be on stable dose for 1 month prior to study enrollment and must stay on that same dose throughout the trial
- Has smart phone or tablet
- Patient willing to use Google-based anonymous email account to sign up for MUSE
- Be willing to provide informed consent and complete all aspects of the study
- Have no contraindicating comorbid health condition which would interfere with the proper use of the Muse-S (trademark) system, as determined by the clinical investigators
Who cannot join
- Pregnant or breastfeeding individuals
- Individuals who have used a regular mindfulness practice or received integrative medicine therapy, including acupuncture/acupressure, mindfulness or stress-reduction programs, massage, and/or energy therapies within the past 60 days
- Currently taking medication for insomnia
- An exclusionary unstable medical or mental health condition as determined by the patient's oncologist
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors
This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors.
II. To evaluate the feasibility of a wearable EEG headband, MUSE S, together with smartphone or tablet application (app) to guide breast cancer survivors' interactive meditation and sleep support.
III. To measure the impact of interactive meditation and sleep support through MUSE S among breast cancer survivors during or after chemotherapy on improving symptoms of anxiety and insomnia.
OUTLINE:
Patients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks.
- Conditions
- Breast Carcinoma
- Being tested
- Electronic Health Record Review, Medical Device Usage and Evaluation, Meditation Therapy, Survey Administration
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Ancillary studies
Medical Device Usage and EvaluationOther
Wear MUSE S headband
Meditation TherapyProcedure or surgery
Also called Meditation
Participate in meditation
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (MUSE S headband, meditation) | Experimental | Patients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks. Receives: Other: Electronic Health Record Review; Other: Medical Device Usage and Evaluation; Procedure: Meditation Therapy; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of use of meditation
Assessed by the number of times participant uses the Muse™ S Headband system and app. Data will be downloaded from the Muse Dashboard to the study team.
Measured: Baseline; 6 weeks
Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband)
Assessed by reviewing usage data and by post-study satisfaction questionnaire adapted from the Was it Worth it Questionnaire (WIWI) asking the patient if the entire research experience, including the intervention, was worth it for them. The WIWI questionnaire includes 3 items: (item 1) Was it worthwhile for you to receive the cancer treatment given in this study? (item 2) If you had to do it over again, would you choose to have this cancer treatment? and (item 3) Would you recommend this cancer treatment to others? Questions are answered with yes, uncertain, or no.
Measured: 6 weeks
Impact of interactive meditation and sleep support through the Muse-S™ system
Assessed by a 3-section questionnaire (sleep, quality of life, and anxiety) with a variety of questions answered by multiple choice (e.g., very well, somewhat well, not very well, not well at all) or answered on a scale of 1-10 where 1=as bad as it can band and 10=as good as it can be.
Measured: Baseline; 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start22 Aug 2025
- Primary completion3 Oct 2025
- Study completion3 Oct 2025
Why it stopped: Funds expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacy D. D'Andre, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274034
- Sponsor's protocol ID
- 23-006870
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT06274034
- Acronym / sponsor ID
- 23-006870
- Conditions
- Breast Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funds expired
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 3 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 23 Feb 2024 (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 early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and insomnia are among the most common distresses in breast cancer survivors during and after chemotherapy, in part due to the side effects of chemotherapy, fear of cancer coming back, progression of the cancer, and uncertainty of the future. These distresses impair patients' well-being and quality of life (QOL) in general, and their cancer treatment adherence and effectiveness in particular. Meditation has been demonstrated to be an effective management tool of stress and anxiety and is given the highest level of evidence (grade A) in the systematic review-based guidelines by the Society of Integrative Medicine. The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed breast cancer patients. The MUSE-S Headband System may decrease anxiety and insomnia among breast cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors.
II. To evaluate the feasibility of a wearable EEG headband, MUSE S, together with smartphone or tablet application (app) to guide breast cancer survivors' interactive meditation and sleep support.
III. To measure the impact of interactive meditation and sleep support through MUSE S among breast cancer survivors during or after chemotherapy on improving symptoms of anxiety and insomnia.
OUTLINE:
Patients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 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 |
|---|---|---|
| Supportive Care (MUSE S headband, meditation) | Experimental | Other: Electronic Health Record Review, Other: Medical Device Usage and Evaluation, Procedure: Meditation Therapy, Other: Survey AdministrationPatients wear the MUSE S headband to bed every night for 8 weeks and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18-80
- Breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years
- Patients report experiencing anxiety and insomnia both rated > 3 on a 0-10 scale (with 0 indicating none) at the time of enrollment
- Patients on anti-anxiety/anti-depressant medication must be on stable dose for 1 month prior to study enrollment and must stay on that same dose throughout the trial
- Has smart phone or tablet
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding individuals
- Individuals who have used a regular mindfulness practice or received integrative medicine therapy, including acupuncture/acupressure, mindfulness or stress-reduction programs, massage, and/or energy therapies within the past 60 days
- Currently taking medication for insomnia
- An exclusionary unstable medical or mental health condition as determined by the patient's oncologist
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 |
|---|---|---|
| Electronic Health Record ReviewAncillary studies | Other | Supportive Care (MUSE S headband, meditation) |
| Medical Device Usage and EvaluationWear MUSE S headband | Other | Supportive Care (MUSE S headband, meditation) |
| Meditation TherapyAlso: MeditationParticipate in meditation | Procedure or surgery | Supportive Care (MUSE S headband, meditation) |
| Survey AdministrationAncillary studies | Other | Supportive Care (MUSE S headband, meditation) |
Primary outcome
Frequency of use of meditation
Time frame: Baseline; 6 weeks
Assessed by the number of times participant uses the Muse™ S Headband system and app. Data will be downloaded from the Muse Dashboard to the study team.
Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband)
Time frame: 6 weeks
Assessed by reviewing usage data and by post-study satisfaction questionnaire adapted from the Was it Worth it Questionnaire (WIWI) asking the patient if the entire research experience, including the intervention, was worth it for them. The WIWI questionnaire includes 3 items: (item 1) Was it worthwhile for you to receive the cancer treatment given in this study? (item 2) If you had to do it over again, would you choose to have this cancer treatment? and (item 3) Would you recommend this cancer treatment to others? Questions are answered with yes, uncertain, or no.
Impact of interactive meditation and sleep support through the Muse-S™ system
Time frame: Baseline; 6 weeks
Assessed by a 3-section questionnaire (sleep, quality of life, and anxiety) with a variety of questions answered by multiple choice (e.g., very well, somewhat well, not very well, not well at all) or answered on a scale of 1-10 where 1=as bad as it can band and 10=as good as it can be.
Results and safety
The study was stopped early (reason given: Funds expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Stacy D. D'Andre, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Electronic Health Record Review, Medical Device Usage and Evaluation and Meditation Therapy in people with Breast Carcinoma, run by Mayo Clinic 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 15 Sep 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funds expired). Results are not available in the source record.
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?
Frequency of use of meditation (time frame: Baseline; 6 weeks). The study lists 3 primary outcomes in all. 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 15 Sep 2026.