A Study of MUSE Device for Midlife Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2025-01-12

Brief Summary

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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

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Detailed Description

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Conditions

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Women's Health Insomnia Sleep Disturbance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Muse-S headband system for management of sleep disturbances

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.

Group Type EXPERIMENTAL

Muse-S™ headband system

Intervention Type DEVICE

Clinical grade, headband-style wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (a smartphone or tablet). The device is a soft, stretchy band that fits around the forehead to the back of the head.

Interventions

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Muse-S™ headband system

Clinical grade, headband-style wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (a smartphone or tablet). The device is a soft, stretchy band that fits around the forehead to the back of the head.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes