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

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Academic

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

Trial Summary

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}

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.

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

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

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 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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

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]

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]