MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors
NCT ID: NCT06274034
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
40 participants
INTERVENTIONAL
2024-01-08
2029-01-31
Brief Summary
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Detailed Description
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I. 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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive Care (MUSE S headband, meditation)
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.
Electronic Health Record Review
Ancillary studies
Medical Device Usage and Evaluation
Wear MUSE S headband
Meditation Therapy
Participate in meditation
Survey Administration
Ancillary studies
Interventions
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Electronic Health Record Review
Ancillary studies
Medical Device Usage and Evaluation
Wear MUSE S headband
Meditation Therapy
Participate in meditation
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Stacy D. D'Andre, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2024-01019
Identifier Type: REGISTRY
Identifier Source: secondary_id
23-006870
Identifier Type: OTHER
Identifier Source: secondary_id
23-006870
Identifier Type: -
Identifier Source: org_study_id