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Search / Trial NCT06274034

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

Launched by MAYO CLINIC · Feb 22, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

The MUSE-S Headband System trial is exploring a new way to help breast cancer survivors who are dealing with anxiety and trouble sleeping, which are common issues after treatment. This study is testing a special meditation headband called the MUSE-S to see if it can make a difference in reducing these feelings. Meditation has been shown to help with stress and anxiety, and the MUSE-S headband has already helped some patients feel better during their treatment.

To be eligible for the trial, participants need to be women aged 18 to 80 who have been diagnosed with breast cancer in the last 10 years and experience anxiety and insomnia. They should have a smartphone or tablet and be willing to use a Google-based email account for the study. Participants will use the headband as part of their daily routine and will be supported throughout the process. Importantly, those who are pregnant, recently practiced mindfulness, or have certain health conditions will not be able to participate.

Gender

FEMALE

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

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Rochester, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Stacy D. D'Andre, MD

Principal Investigator

Mayo Clinic in Rochester

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported