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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amber Klindworth, PA-C | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Inter-Quartile Range | score on a scale | Baseline, 3 months, 6 months |
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Adverse events were collected from the time of informed consent through study completion, approximately 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amber Klindworth, P.A.-C. | Mayo Clinic | 507-538-7103 | Klindworth.Amber@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2024 | Dec 30, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Baseline, 3 months, 6 months |
| 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. With higher scores indicating more severe anxiety. | Baseline, 3 months, 6 months |
| 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. | Baseline, 3 months, 6 months |
| 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. | Baseline, 3 months, 6 months |
| 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. With higher scores indicating more severe depression. | Baseline, 3 months, 6 months |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | 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. | Posted | Median | Full Range | score on a scale | Baseline, 3 months, 6 months |
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| Secondary | 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). | 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. | Posted | Median | Full Range | score on a scale | Baseline, 3 months, 6 months |
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| Secondary | 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. With higher scores indicating more severe anxiety. | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 3 months, 6 months |
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| Secondary | 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. | Only 14 subjects are included in the FSFI scores at 3 months and 6 months as only 14 subjects returned their questionnaire. | Posted | Median | Full Range | score on a scale | Baseline, 3 months, 6 months |
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| Secondary | 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. | 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. | Posted | Median | Full Range | score on a scale | Baseline, 3 months, 6 months |
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| Secondary | 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. With higher scores indicating more severe depression. | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 3 months, 6 months |
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| 0 |
| 31 |
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| 31 |
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| D001523 |
| Mental Disorders |
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| 6 Months |
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| 6 Months |
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| 3 Months to 6 Months |
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| 6 Months |
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| 6 Months |
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| 3 Months to 6 Months |
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