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Behavioural Intervention

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

Phase < 1

Recruiting

Led By Stacy D. D'Andre, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18-80

Breast cancer first diagnosed with stage 1-4 breast cancer in the past 10 years

Must not have

Currently taking medication for insomnia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a meditation headband system called MUSE-S to see if it can help breast cancer survivors with anxiety and insomnia. These issues are common among breast cancer survivors and can affect their well

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves non-invasive meditation therapy with a headband, there are minimal expected side effects. However, discomfort or skin irritation from wearing the device may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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My breast cancer was first diagnosed within the last 10 years.

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I am experiencing anxiety and insomnia, both worse than 3 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on medication for insomnia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of a wearable electroencephalographic (EEG) headband (Muse™ S Headband)

Frequency of use of meditation

Impact of interactive meditation and sleep support through the Muse-S™ system

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Supportive Care (MUSE S headband, meditation)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meditation Therapy

2018

N/A

~50

0 / 4Eligibility criteria met