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

Recruiting in Palo Alto (17 mi)

Overseen by Stacy D. D'Andre, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must be taking: Anti-anxiety, Antidepressants

Must not be taking: Insomnia medications

Disqualifiers: Pregnancy, Breastfeeding, Unstable conditions, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the MUSE-S Headband System treatment for anxiety and insomnia in breast cancer survivors?

The research on EEG biofeedback (a technique that uses brainwave monitoring to improve mental health) suggests it may help reduce cognitive issues, fatigue, sleep problems, and psychological symptoms in breast cancer survivors. This indicates that similar EEG-based treatments, like the MUSE-S Headband, could potentially be effective for anxiety and insomnia in this group. ^{1 2 3 4 5}

How is the MUSE-S Headband treatment different from other treatments for anxiety and insomnia in breast cancer survivors?

The MUSE-S Headband is unique because it uses a wearable device to provide real-time feedback on brain activity, helping users practice mindfulness and relaxation techniques, unlike traditional treatments like cognitive behavioral therapy or medication. ^{4 6 7 8 9}

Research Team

Stacy D. D'Andre, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• MUSE-S Headband System (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

Approved in Canada as Muse S Headband for:

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3427

Patients Recruited

3,221,000+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep disturbance among breast cancer survivors and controls from midlife to early older adulthood: Pink SWAN. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Sleep macro- and microstructure in breast cancer survivors. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cancer-related problems, sleep quality, and sleep disturbance among long-term cancer survivors at 9-years post diagnosis. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of cognitive behavioral therapy for insomnia in breast cancer: A meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of EEG biofeedback on reducing postcancer cognitive impairment. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Randomized trial of a cognitive-behavioral intervention for insomnia in breast cancer survivors. [2018]

7. England 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Sleep reactivity predicts insomnia in patients diagnosed with breast cancer. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. [2021]