Back to resultsA Study of MUSE Device for Midlife Women
Primary Purpose
Women's Health, Insomnia, Sleep Disturbance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Muse-S™ headband system
Sponsored by
About this trial
This is an interventional treatment trial for Women's Health
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic MinnesotaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Muse-S headband system for management of sleep disturbances
Arm 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.
Outcomes
Primary Outcome Measures
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.
Change in 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: 0 - never; 1 - rarely; 2 - sometimes; 3 - often, and 4 - always. Possible scores range from 0 to 24, with lower scores indicating a better outcome.
Secondary Outcome Measures
Change in perceived stress levels
Measured using the self-reported Perceived Stress Scale (PSS). The 10-item questionnaire measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).
Change in perceived anxiety
Measured using the self-reported Generalized Anxiety Disorder Scale (GAD-7). The 7-item questionnaire assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.
Change in sexual function
Measured using the self-reported Female Sexual Function Index (FSFI). The 19-item questionnaire to assess the sexual functioning in women. The questions in this assessment tool ask participants about a specific sexual function within the past 4 weeks on a Likert scale range of 0-5. Total scores range from 2 to 36, with lower scores indicating worse sexual functioning.
Change in sexual distress
Measured using the Female Sexual Distress Scale (FSDS-R). The 13-item questionnaire to assess sexually related personal distress over the pas 30 days. The questions in this assessment tool asks how often the participant felt during the past month. Possible answers include: 0 - never; 1 - rarely; 2 - occasionally; 3 - frequently, and 4 - always. Possible scores range from 0 to 60, with higher scores indicating greater level of distress.
Change in quality of life
Measured using the self-reported Patient Health Questionnaire (PHQ-9). The 9-item questionnaire used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05972486
Brief Title
A Study of MUSE Device for Midlife Women
Official Title
MUSE Device to Improve Sleep Quality in Midlife Women
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Women's Health, Insomnia, Sleep Disturbance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muse-S headband system for management of sleep disturbances
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Muse-S™ headband system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in quality of sleep
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Change in sleep impact
Description
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: 0 - never; 1 - rarely; 2 - sometimes; 3 - often, and 4 - always. Possible scores range from 0 to 24, with lower scores indicating a better outcome.
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Change in perceived stress levels
Description
Measured using the self-reported Perceived Stress Scale (PSS). The 10-item questionnaire measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).
Time Frame
Baseline, 3 months, 6 months
Title
Change in perceived anxiety
Description
Measured using the self-reported Generalized Anxiety Disorder Scale (GAD-7). The 7-item questionnaire assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety.
Time Frame
Baseline, 3 months, 6 months
Title
Change in sexual function
Description
Measured using the self-reported Female Sexual Function Index (FSFI). The 19-item questionnaire to assess the sexual functioning in women. The questions in this assessment tool ask participants about a specific sexual function within the past 4 weeks on a Likert scale range of 0-5. Total scores range from 2 to 36, with lower scores indicating worse sexual functioning.
Time Frame
Baseline, 3 months, 6 months
Title
Change in sexual distress
Description
Measured using the Female Sexual Distress Scale (FSDS-R). The 13-item questionnaire to assess sexually related personal distress over the pas 30 days. The questions in this assessment tool asks how often the participant felt during the past month. Possible answers include: 0 - never; 1 - rarely; 2 - occasionally; 3 - frequently, and 4 - always. Possible scores range from 0 to 60, with higher scores indicating greater level of distress.
Time Frame
Baseline, 3 months, 6 months
Title
Change in quality of life
Description
Measured using the self-reported Patient Health Questionnaire (PHQ-9). The 9-item questionnaire used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
Time Frame
Baseline, 3 months, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Cruz, ACRC
Phone
507-284-5404
Email
Cruz.Katie@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber Klindworth, PA-C
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Cruz
Email
cruz.katie@mayo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
A Study of MUSE Device for Midlife Women
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