A Study of MUSE Device for Midlife Women

Mayo Clinic

Status: Completed

Conditions: Women's Health; Insomnia; Sleep Disturbance

Treatments: Device: Muse-S™ headband system

Study type: Interventional

Funder types: Other

Identifiers

NCT05972486

23-000081

Details and patient eligibility

About

The purpose of this study is to see if it is feasible for midlife women to wear a brain activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and sleep disruption

Enrollment: 31 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women in the menopause transition or in menopause, based on clinical assessment
• PSQI score > 5, with overall sleep quality rating of "fairly bad" or "very bad".
• Motivation VAS score equal to or greater than 5 with overall motivation rating of on a scale of 0-10 with 0 being not motivated at all and 10 being extremely motivated.
• Access to an iPad, iPhone, or android device.
• Have ability to provide informed consent.

Exclusion criteria

• Suspected or confirmed obstructive sleep apnea.
• Moderate to severe vasomotor symptoms warranting prescription medication use. The FDA categories for hot flash severity are classified as mild (sensation of heat without sweating), moderate (sensation of heat with sweating, able to continue activity), or severe (sensation of heat with sweating cause cessation of activity).
• Use of hormone therapy or hypnotic agents.
• Use of supplements known to affect sleep.
• A known, active, untreated clinically significant psychiatric condition.
• 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.
• Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Muse-S headband system for management of sleep disturbances

Experimental group

Description:

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.

Treatment:

Device: Muse-S™ headband system