Muse Headband for Insomnia in Midlife Women

Overseen By Katie Cruz, ACRC

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Hormone therapy, Hypnotic agents

Disqualifiers: Sleep apnea, Vasomotor symptoms, Psychiatric condition, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if midlife women can use a special headband to manage sleep problems like insomnia. The headband monitors brain activity to provide feedback that can help improve sleep patterns.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking hormone therapy, hypnotic agents, and supplements known to affect sleep to participate in the trial.

How does the Muse Headband treatment for insomnia in midlife women differ from other treatments?

The Muse Headband is unique because it likely uses biofeedback or neurofeedback technology to help improve sleep, which is different from traditional treatments like cognitive behavioral therapy or medications. This approach may offer a non-drug alternative for managing insomnia, focusing on real-time brain activity monitoring to promote relaxation and better sleep patterns. ^{1 2 3 4 5}

Research Team

Amber Klindworth, PA-C

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for midlife women experiencing menopause-related sleep disturbances who have access to a smart device and are motivated to improve their sleep. They must not be using supplements affecting sleep, have untreated significant psychiatric conditions, or be practicing mindfulness regularly.

Inclusion Criteria

I am going through or have completed menopause.

I often sleep poorly.

I rate my motivation for treatment as 5 or higher on a scale of 0 to 10.

Exclusion Criteria

Use of an investigational drug within 30 days of study enrollment or presence of a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence

I have been practicing mindfulness regularly for the past 3 weeks.

I experience moderate to severe hot flashes that require medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a Muse-S headband system and are asked to use it daily for a minimum of 10 minutes, with three sessions per week focused on mind meditation

24 weeks

Baseline, 3 months, 6 months

Follow-up

Participants are monitored for changes in sleep impact, quality of sleep, perceived stress, anxiety, sexual function, sexual distress, and quality of life

4 weeks

Treatment Details

Interventions

• Muse-S™ headband system

Trial Overview The study tests the feasibility of using the Muse-S headband system by midlife women with insomnia or other sleep disorders. The headband senses brain activity and aims to help manage these disturbances.

Participant Groups

Group I: Muse-S headband system for management of sleep disturbances Experimental Treatment 1 Intervention

Study participants will receive a new Muse-S headband system at study entry and will be asked to utilize it daily for a minimum of 10 minutes day for a period of 6 months (24 weeks). Three of the seven sessions per week will specifically be asked to be mind meditation.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Cognitive Behavioral Therapy for Insomnia (CBT-I) is strongly recommended as the first-line treatment for chronic insomnia in adults, supported by high-quality evidence from systematic reviews.

Pharmacological treatments, such as benzodiazepines and certain antidepressants, can be used for short-term relief of insomnia, but other options like antihistamines and complementary therapies are not recommended due to low-quality evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guideline for the diagnosis and treatment of insomnia. Riemann, D., Baglioni, C., Bassetti, C., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Armodafinil to reduce the sleepiness related side-effects of sleep restriction therapy being used to treat insomnia disorder: An open label clinical trial pilot study compared with historical controls. [2023]

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

European guideline for the diagnosis and treatment of insomnia. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Subjective insomnia is associated with low sleep efficiency and fatigue in middle-aged women. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Associations between anxiety, depression and insomnia in peri- and post-menopausal women. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

The effect of sleep hygiene education and relaxation exercises on insomnia among postmenopausal women: A randomized clinical trial. [2018]