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MUSE-S Headband for Anxiety and Insomnia in Breast Cancer Survivors

This study is looking at how well a special headband system, called MUSE-S, can help breast cancer survivors with anxiety and trouble sleeping (insomnia). Many breast cancer survivors experience these issues due to treatment side effects or worries about their health. Meditation is a proven way to manage stress, and this study wants to see if the MUSE-S system, which guides meditation and sleep support, is easy to use and helps improve these symptoms. You might be able to join if you are a woman between 18 and 80 years old, were diagnosed with breast cancer in the last 10 years, and currently experience anxiety and insomnia. The study aims to see how often people use the meditation, if the headband is practical, and if it helps reduce anxiety and insomnia.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is an early phase trial focused on feasibility and impact.
What's involved
You would wear the MUSE S headband to bed every night for 8 weeks and use the MUSE phone app for at least 5 minutes of meditation daily for 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at baseline and after 6 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06274034

MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors

Recruiting
EARLY_PHASE1Ages 18–80InterventionalSupportive care
Mayo Clinic
~20 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Electronic Health Record ReviewMedical Device Usage and EvaluationMeditation TherapySurvey Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of use of meditation
Measured over Baseline; 6 weeks
+2 more outcomes measured

Conditions

Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Stacy D. D'Andre, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Frequency of use of meditationBaseline; 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)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™ systemBaseline; 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.