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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06274034
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Medical Device Usage and Evaluation — OTHER
    Wear MUSE S headband
  • Meditation Therapy — PROCEDURE
    Participate in meditation
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jan 8, 2024
Status verified
May 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.

Primary Outcome Measure

Frequency of use of meditation [ Time Frame: Baseline; 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Stacy D. D'Andre, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mayo Clinic in Rochester· Rochester, MN

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