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

Last updated: January 13, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Cancer/tumors

Treatment

Medical Device Usage and Evaluation

Survey Administration

Electronic Health Record Review

Clinical Study ID

NCT06274034
23-006870
NCI-2024-01019
23-006870
  • Ages 18-80
  • Female

Study 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

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 1month 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 theproper use of the Muse-S (trademark) system, as determined by the clinicalinvestigators

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding individuals

  • Individuals who have used a regular mindfulness practice or received integrativemedicine therapy, including acupuncture/acupressure, mindfulness or stress-reductionprograms, 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 thepatient's oncologist

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Medical Device Usage and Evaluation
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
January 31, 2029

Study Description

PRIMARY OBJECTIVES:

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.

Connect with a study center

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

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