A Study of MUSE Device for Midlife Women

NCT05972486 | Completed Results FDA Device

• 1 other identifier: 23-000081
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Women's Health; Insomnia; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Sleep

  Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.

  Baseline, 3 months, 6 months

• Sleep Impact

  Measured using the self-reported ASCQ-Me Sleep Impact Short Form. The 5-item questionnaire used to assess functioning and wellbeing in accordance with sleep. The questions in this assessment tool ask how often they felt sleep impacted specific activities during the the past 7 days. Possible answers include: 5 - never; 4 - rarely; 3 - sometimes; 2 - often, and 1 - always. Possible scores range from 5 to 25, with higher scores indicating a better outcome.

  Baseline, 3 months, 6 months

Secondary Outcomes (5)

• Perceived Stress Levels

  Baseline, 3 months, 6 months

• Change in Perceived Anxiety

  Baseline, 3 months, 6 months

• Sexual Function

  Baseline, 3 months, 6 months

• Sexual Distress

  Baseline, 3 months, 6 months

• Change in Quality of Life

  Baseline, 3 months, 6 months

Study Arms (1)

Muse-S headband system for management of sleep disturbances

EXPERIMENTAL

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.

Device: Muse-S™ headband system

Interventions

Muse-S™ headband system 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.

Muse-S headband system for management of sleep disturbances

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Suspected or untreated 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Amber Klindworth, P.A.-C.
• Organization: Mayo Clinic

Klindworth.Amber@mayo.edu

507-538-7103

Study Officials

• Amber Klindworth, PA-C

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: August 1, 2023
• Primary Completion: January 12, 2025
• Study Completion: January 12, 2025
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)