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

NCT06274034 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-16

No results posted yet for this 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.

Conditions

  • Breast Carcinoma

Interventions

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Medical Device Usage and Evaluation

Wear MUSE S headband

PROCEDURE

Meditation Therapy

Participate in meditation

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06274034 on ClinicalTrials.gov