Trial Outcomes & Findings for A Study of MUSE Device for Midlife Women (NCT NCT05972486)
NCT ID: NCT05972486
Last Updated: 2026-01-26
Results Overview
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.
COMPLETED
NA
31 participants
Baseline, 3 months, 6 months
2026-01-26
Participant Flow
Participant milestones
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Overall Study
STARTED
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31
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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17
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Reasons for withdrawal
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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17
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Baseline Characteristics
A Study of MUSE Device for Midlife Women
Baseline characteristics by cohort
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
n=31 Participants
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=41 Participants
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Age, Categorical
Between 18 and 65 years
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31 Participants
n=41 Participants
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Age, Categorical
>=65 years
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0 Participants
n=41 Participants
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Sex: Female, Male
Female
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31 Participants
n=41 Participants
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Sex: Female, Male
Male
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0 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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31 Participants
n=41 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=41 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=41 Participants
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Race (NIH/OMB)
White
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29 Participants
n=41 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=41 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=41 Participants
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Region of Enrollment
United States
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31 participants
n=41 Participants
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PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 4 subjects are not included in the change in quality of sleep from baseline to 6-month or change in quality of sleep from 3 months to 6-months as only 14 subjects completed the study through the 6-month time point.
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.
Outcome measures
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
n=18 Participants
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Change in Quality of Sleep
Baseline to 3 Months
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-3 score on a scale
Interval -4.0 to -2.0
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Change in Quality of Sleep
Baseline to 6 Months
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-4 score on a scale
Interval -9.0 to -3.0
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Change in Quality of Sleep
3 Months to 6 Months
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-1 score on a scale
Interval -3.0 to 0.0
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PRIMARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 13 subjects are not included in the sleep impact score at 3 months as only 18 subjects completed the study through the 3-month time point. 17 subjects are not included in the sleep impact score at 6 months as only 14 subjects completed the study through the 6-month time point.
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.
Outcome measures
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
n=31 Participants
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Sleep Impact
Baseline
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18 score on a scale
Interval 8.0 to 25.0
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Sleep Impact
3 Months
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22 score on a scale
Interval 14.0 to 25.0
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Sleep Impact
6 Months
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23 score on a scale
Interval 14.0 to 25.0
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SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 13 subjects are not included in the perceived stress levels score at 3 months as only 18 subjects completed the study through the 3-month time point. 17 subjects are not included in the perceived stress levels score at 6 months as only 14 subjects completed the study through the 6-month time point.
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).
Outcome measures
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
n=31 Participants
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Perceived Stress Levels
Baseline
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16 score on a scale
Interval 1.0 to 27.0
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Perceived Stress Levels
3 Months
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12 score on a scale
Interval 2.0 to 21.0
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Perceived Stress Levels
6 Months
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12 score on a scale
Interval 4.0 to 22.0
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SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 4 subjects are not included in the change in perceived anxiety from baseline to 6-month or change in perceived anxiety from 3 months to 6-months as only 14 subjects completed the study through the 6-month time point
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. With higher scores indicating more severe anxiety.
Outcome measures
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
n=18 Participants
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Change in Perceived Anxiety
Baseline to 3 Months
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-2 score on a scale
Interval -3.0 to -1.0
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Change in Perceived Anxiety
Baseline to 6 Months
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-2 score on a scale
Interval -4.0 to 0.0
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Change in Perceived Anxiety
3 Months to 6 Months
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0 score on a scale
Interval -5.0 to 3.0
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SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: Only 14 subjects are included in the FSFI scores at 3 months and 6 months as only 14 subjects returned their questionnaire.
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.
Outcome measures
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
n=21 Participants
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Sexual Function
Baseline
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18 score on a scale
Interval 2.0 to 34.0
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Sexual Function
3 Months
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18 score on a scale
Interval 4.0 to 34.0
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Sexual Function
6 Months
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21 score on a scale
Interval 3.0 to 33.0
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SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 8 subjects are not included in the female sexual distress score at 3 months as only 18 subjects completed the study through the 3-month time point. 12 subjects are not included in the female sexual distress score at 6 months as only 14 subjects completed the study through the 6-month time point.
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.
Outcome measures
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
n=26 Participants
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Sexual Distress
Baseline
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23.5 score on a scale
Interval 13.0 to 53.0
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Sexual Distress
3 Months
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24 score on a scale
Interval 13.0 to 50.0
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Sexual Distress
6 Months
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18 score on a scale
Interval 12.0 to 41.0
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SECONDARY outcome
Timeframe: Baseline, 3 months, 6 monthsPopulation: 4 subjects are not included in the change in quality of life from baseline to 6-month or change in quality of life from 3 months to 6-months as only 14 subjects completed the study through the 6-month time point
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. With higher scores indicating more severe depression.
Outcome measures
| Measure |
Muse-S Headband System for Management of Sleep Disturbances
n=18 Participants
Study participants received a new Muse-S headband system at study entry and were 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 were specifically be asked to be mind meditation.
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.
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|---|---|
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Change in Quality of Life
Baseline to 3 Months
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-2 score on a scale
Interval -3.0 to -1.0
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Change in Quality of Life
Baseline to 6 Months
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-2 score on a scale
Interval -3.0 to -1.0
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Change in Quality of Life
3 Months to 6 Months
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0 score on a scale
Interval -3.0 to 1.0
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Adverse Events
Muse-S Headband System for Management of Sleep Disturbances
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place