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

StatusTerminated
PhaseEarly Phase 1
Started2025-08-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
Trial terminated: Funds expired
Final enrollment: 14 participants (planned 20)
Primary completion confirmed: October 2025 (last estimated January 2029)
2026-05-29
Study Identification, Study Status, Study Design v5
Enrollment target40→20
2025-12-12
Study Status v4
Re-verified, no change to tracked fields
2025-07-09
Study Identification, Study Status, Oversight, Contacts/Locations v3
Study sitescontacts updated at 1 of 1 site
2025-01-13
Study Identification, Study Status, Oversight, Contacts/Locations v2
Primary completion date2025-01-31→2029-01-31
Completion date2025-01-31→2029-01-31
Study sitescontacts updated at 1 of 1 site
2024-07-19
Study Status v1
Re-verified, no change to tracked fields
2024-02-22
Original filing
Mayo Clinic
1,015 trials monitored
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Breast Cancer
5,180 trials monitored
See 256 trials at risk
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.
Trial Details
NCT Number NCT06274034
Lead Sponsor Mayo Clinic
Conditions Breast Carcinoma
Enrollment 14 participants
Start Date 2025-08-22
Primary Completion 2025-10-03 (estimated)
Study Completion 2025-10-03 (estimated)
Updated on ClinicalTrials.gov 2026-09-15