NCT06274034 MUSE-S Headband System for Improving Anxiety and Insomnia Among Breast Cancer Survivors
| NCT ID | NCT06274034 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Mayo Clinic |
| Condition | Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-01-08 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Stacy D. D'Andre, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic in Rochester
Frequently Asked Questions
Who can join the NCT06274034 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 80 Years, studying Breast Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06274034 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06274034 currently recruiting?
Yes, NCT06274034 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT06274034 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT06274034 clinical trial?
NCT06274034 is sponsored by Mayo Clinic. The principal investigator is Stacy D. D'Andre, MD at Mayo Clinic in Rochester. The trial plans to enroll 20 participants.