RecruitingEarly Phase 1NCT06274034

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

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors

Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Carcinoma

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

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using the MUSE-S headband — a consumer wearable that guides meditation and sleep using brain wave monitoring — can reduce anxiety and insomnia in breast cancer survivors. **You may be eligible if...** - You are between 18 and 80 years old - You were diagnosed with stage 1–4 breast cancer within the past 10 years - You currently experience both anxiety and insomnia, each rated above 3 out of 10 - You own or can use a smartphone or tablet - If you are on anti-anxiety or antidepressant medication, you have been on a stable dose for at least 1 month **You may NOT be eligible if...** - You have a serious health condition that would interfere with using the device - You are not willing to use a Google-based email account to sign up for the MUSE app - You are unwilling or unable to complete all study activities Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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