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

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must be taking: Anti-anxiety, Antidepressants

Must not be taking: Insomnia medications

Disqualifiers: Pregnancy, Breastfeeding, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

40 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 5 6 7 8}

Who Is on the Research Team?

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.

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

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?

Group I: Supportive Care (MUSE S headband, meditation) Experimental Treatment 4 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.

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

Approved in United States as Muse S Headband for:

• Anxiety management
• Insomnia management
• Stress management in breast cancer survivors

Approved in Canada as Muse S Headband for:

• Anxiety management
• Insomnia management
• Stress management in breast cancer survivors

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 173 women with breast cancer over 9 months, those with high sleep reactivity were more likely to experience worsening insomnia, indicating that sleep reactivity is a significant predictor of insomnia in this population.

The findings suggest that assessing sleep reactivity during clinical evaluations could help identify breast cancer patients at risk for insomnia, allowing for early interventions to improve their sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep reactivity predicts insomnia in patients diagnosed with breast cancer. Rehman, A., Drake, CL., Shiramizu, V., et al.[2023]

Breast cancer survivors who completed radiotherapy showed significant sleep disturbances compared to healthy controls, including more awakenings and altered sleep structure as measured by polysomnography.

The study found that these patients had increased cortical activity related to arousal and decreased activity related to sleep deepening, indicating a disruption in sleep homeostasis even after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep macro- and microstructure in breast cancer survivors. Perrier, J., Duivon, M., Clochon, P., et al.[2022]

A 6-month study involving 23 female breast cancer survivors showed that EEG biofeedback (neurofeedback) is feasible and can significantly improve cognitive impairment, fatigue, and psychological symptoms associated with postcancer cognitive impairment (PCCI).

Participants experienced strong improvements across multiple measures, including cognitive function and sleep quality, with results maintained even 4 weeks after the neurofeedback training, indicating its potential as a restorative intervention for PCCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of EEG biofeedback on reducing postcancer cognitive impairment. Alvarez, J., Meyer, FL., Granoff, DL., et al.[2022]

Breast cancer survivors (BCS) did not experience an increase in sleep disturbances, specifically frequent nighttime awakenings, when comparing the 5 years before and after their diagnosis to women without cancer, based on a study involving 152 BCS and 2163 controls over 20 years.

Among BCS, three distinct sleep trajectory groups were identified, indicating that while most had stable sleep patterns, a significant portion (33%) showed increasing sleep disturbances starting 2 years before diagnosis, suggesting the need for monitoring and potential treatment for those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disturbance among breast cancer survivors and controls from midlife to early older adulthood: Pink SWAN. Goyal, N., Levine, BJ., Crawford, SL., et al.[2023]

A 6-week randomized controlled trial will assess the effectiveness of voice-activated cognitive behavioral therapy for insomnia (CBT-I) in breast cancer survivors, who often experience insomnia at rates of 30-50%.

The study aims to compare the efficacy of this innovative delivery method against a sleep education control, with the primary outcome being the Insomnia Severity Index score, which will help determine if this approach can effectively reduce insomnia symptoms in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing delivery of components of cognitive behavioral therapy for insomnia to breast cancer survivors by smart speaker: a study protocol. Starling, CM., Greenberg, D., Zhou, E., et al.[2022]

In a study of 1,903 long-term cancer survivors, 20% reported poor sleep quality and 51% experienced high sleep disturbance, indicating significant sleep difficulties in this population.

The strongest association with sleep problems was found with cancer-related physical distress, where higher levels of distress increased the odds of poor sleep quality by 3.42 times and high sleep disturbance by 4.06 times, highlighting the need for targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-related problems, sleep quality, and sleep disturbance among long-term cancer survivors at 9-years post diagnosis. Strollo, SE., Fallon, EA., Gapstur, SM., et al.[2020]

Citations

1. trialx.com trialx.com/clinical-trials/listings/285268/muse-s-headband-system-for-improving-anxiety-and-insomnia-among-breast-cancer-survivors/

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6769228/

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.

3. cancer.gov cancer.gov/clinicaltrials/NCI-2024-01019

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 ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/73/NCT04743973/Prot_000.pdf

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 ...

5. withpower.com withpower.com/trial/early-phase-1-breast-carcinoma-2024-7b9f2

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 ...

6. choosemuse.my.site.com choosemuse.my.site.com/s/article/Muse-Health-and-Safety

Muse Health and Safety Muse 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?

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10041582/

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 ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/33/NCT05199233/Prot_SAP_000.pdf

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™ ...