Using a meditation headband to help breast cancer survivors with anxiety and insomnia
Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors
This study is testing whether a meditation headband can help breast cancer survivors reduce anxiety and improve sleep by using it with a smartphone app for eight weeks.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06274034 on ClinicalTrials.gov |
What this trial studies
This early phase I trial evaluates the feasibility and impact of the MUSE-S headband system, designed to assist breast cancer survivors in managing anxiety and insomnia. Participants will wear the headband nightly for 8 weeks and engage in guided meditation through a smartphone app for at least 5 minutes each day. The study aims to assess the frequency of meditation use, the feasibility of the wearable device, and the overall impact on symptoms of anxiety and insomnia among survivors during or after chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors aged 18-80 who have been diagnosed within the past 10 years and report moderate to severe anxiety and insomnia.
Not a fit: Patients who are pregnant, breastfeeding, or have prior experience with mindfulness practices may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental well-being and quality of life for breast cancer survivors experiencing anxiety and insomnia.
How similar studies have performed: Previous studies have shown that meditation techniques can effectively reduce stress and improve quality of life in cancer patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Stacy D. D'Andre, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.