40 Participants Needed

MUSE-S Headband for Anxiety and Insomnia in Breast Cancer Survivors

CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Female
Trial Phase: Phase < 1
Sponsor: Mayo Clinic
Must be taking: Anti-anxiety, Antidepressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the MUSE-S headband, a meditation aid, can reduce anxiety and insomnia in breast cancer survivors. These symptoms often trouble survivors and affect their daily lives and treatment. Participants will wear the headband to bed and meditate using a phone app. This trial may suit breast cancer survivors diagnosed in the last 10 years who currently experience anxiety and insomnia. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to explore this innovative approach.

Will I have to stop taking my current medications?

If you are taking anti-anxiety or anti-depressant medication, you must be on a stable dose for at least one month before joining the trial and continue on that same dose during the trial. If you are taking medication for insomnia, you cannot participate in this trial.

What prior data suggests that the MUSE-S Headband is safe for breast cancer survivors?

Research has shown that the MUSE-S Headband System is generally safe for users. This headband uses sensors to aid meditation and has been found to reduce stress and improve the quality of life for breast cancer patients. Studies have not identified any serious side effects from using the headband. As this trial is in the early stages, it aims to determine if patients can use the headband comfortably. Early trials like this typically ensure treatments are safe before further testing.12345

Why are researchers excited about this trial?

The MUSE-S Headband system is unique because it offers a non-pharmaceutical approach to managing anxiety and insomnia, specifically for breast cancer survivors. Unlike standard treatments like medication or therapy, this system combines wearable technology with meditation practices. The headband uses advanced sensors to track brain activity and guide users through meditation sessions via a phone app, providing a personalized and holistic way to improve mental health and sleep quality. Researchers are excited about its potential to empower patients with a drug-free solution that can easily fit into their daily routines.

What evidence suggests that the MUSE-S Headband is effective for anxiety and insomnia in breast cancer survivors?

Research has shown that meditation can help manage stress and anxiety, which is important for breast cancer survivors. In this trial, participants will use the MUSE-S Headband, a wearable device that senses brain activity, to explore its potential benefits. The MUSE-S Headband has shown promise in helping with fatigue, quality of life, and stress in patients recently diagnosed with breast cancer. These benefits suggest the device might also help with anxiety and trouble sleeping. Although more research is needed, early results encourage those facing these issues after breast cancer treatment.15678

Who Is on the Research Team?

SD

Stacy D. D'Andre, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who are experiencing anxiety and insomnia. Participants should be interested in trying a meditation headband system called MUSE-S to help manage their stress.

Inclusion Criteria

Has smart phone or tablet
Be willing to provide informed consent and complete all aspects of the study
I have been on a stable dose of my anti-anxiety or anti-depressant medication for at least 1 month.
See 4 more

Exclusion Criteria

I am currently on medication for insomnia.
I have practiced mindfulness or received integrative medicine therapy in the last 60 days.
Pregnant or breastfeeding individuals
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the MUSE S headband to bed every night and meditate using the MUSE phone app during day hours for at least 5 minutes over 8 weeks

8 weeks
Daily use of headband and app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MUSE-S Headband System
Trial Overview The study is testing the MUSE-S Headband System, which guides users through meditation using EEG technology. It aims to see if this device can improve well-being by reducing anxiety and insomnia among breast cancer survivors.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Supportive Care (MUSE S headband, meditation)Experimental Treatment4 Interventions

MUSE-S Headband System is already approved in United States, Canada for the following indications:

🇺🇸
Approved in United States as Muse S Headband for:
🇨🇦
Approved in Canada as Muse S Headband for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in reducing insomnia and improving sleep quality in breast cancer survivors, with a significant pooled effect size of -0.779 based on 14 randomized controlled trials involving 1363 participants.
The benefits of CBT-I for insomnia persist over time, showing medium-to-large effect sizes at both short-term (within six months) and long-term (12 months) follow-ups, indicating its lasting impact on sleep quality for women treated for breast cancer.
Efficacy of cognitive behavioral therapy for insomnia in breast cancer: A meta-analysis.Ma, Y., Hall, DL., Ngo, LH., et al.[2022]
A randomized controlled trial involving 72 breast cancer survivors showed that a cognitive-behavioral intervention significantly improved various sleep metrics, including sleep-onset latency and total sleep time, compared to a single-component control group.
Both the multicomponent intervention and the simpler sleep education and hygiene approach were effective in treating insomnia, indicating that nonpharmacologic strategies can benefit breast cancer survivors dealing with sleep issues.
Randomized trial of a cognitive-behavioral intervention for insomnia in breast cancer survivors.Epstein, DR., Dirksen, SR.[2018]
In a pilot study involving 21 breast cancer survivors, individual cognitive behavioral therapy for insomnia (IND-CBT-I) significantly improved self-rated insomnia and sleep quality compared to a delayed treatment control group.
The results suggest that IND-CBT-I is a practical and effective option for improving sleep in breast cancer survivors, making it accessible in outpatient settings.
Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study.Fiorentino, L., McQuaid, JR., Liu, L., et al.[2021]

Citations

MUSE-S Headband System for Improving Anxiety and ...This early phase I trial evaluates the feasibility and impact of a meditation headband system (MUSE-S) for breast cancer survivors. Anxiety and ...
Use of a Wearable EEG Headband as a Meditation Device ...In conclusion, use of a wearable, EEG device such as the Muse by patients with newly diagnosed breast cancer is feasible and improves fatigue, QOL, and stress.
MUSE-S Headband System for Improving Anxiety and ...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 ...
A Feasibility study evaluating Mindfulness-B○ The Muse-S™ Headband system: The Muse-S™ Headband system is a brain sensing headband that measures brain activity by detecting electrical impulses ...
MUSE-S Headband for Anxiety and Insomnia in Breast Cancer ...The portable, interactive, electroencephalographic (EEG) Muse headband guided meditation has been shown to improve fatigue, QOL, and stress in newly diagnosed ...
Muse Health and SafetyMuse Health and Safety. This page shares some key information and answers common questions about the health and safety of Muse devices. Is Muse safe to use?
Mindfulness Using a Wearable Brain Sensing Device for ...The Muse-S™ Headband system has 7 sensors with 4 channels of EEG data for an accurate, high-quality experience. In this study, all participants ...
The Benefit of Mindfulness-Based Intervention Using A ...Muse-S™ is a clinical grade, headband-style wireless EEG system designed to interact with a mobile device (a ... Intervention: ○ The Muse-S™ ...
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