NCT06274034

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

Pilot Study of a Wearable EEG Headband as a Meditation Device for Breast Cancer Survivors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the frequency of use of meditation (a stress management technique) among breast cancer survivors. II. To evaluate the feasibility of a wearable EEG headband, MUSE S, together with smartphone or tablet application (app) to guide breast cancer survivors' interactive meditation and sleep support. III. To measure the impact of interactive meditation and sleep support through MUSE S among breast cancer survivors during or after chemotherapy on improving symptoms of anxiety and insomnia. OUTLINE: 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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-08
• Primary completion: 2029-01-31
• Completion: 2029-01-31
• First posted: 2024-02-23
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States