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| Name | Class |
|---|---|
| Biomobie | UNKNOWN |
| Harvard University | OTHER |
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The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.
Insomnia is a common health complaint that is associated with discomfort, loss of productivity, poor health and higher use of healthcare. The use of non-pharmacologic treatments for insomnia has gained much attention in recent years. The investigators are conducting this research because a safe, non-pharmacologic treatment would benefit patients with insomnia, and to see if the Bioboosti device is an effective treatment for insomnia.
Subjects will include patients from the clinics who have the diagnosis of insomnia. Study staff will notify the treating physician of a potential subject. If the subject gives permission and would like to obtain more information, study staff will approach them and provide them with the consent form to review. Study staff may also contact them by phone to explain the study and recruit.
Subjects will be asked to make 5 visits:
Visit 1-- consent form, physical exam, vitals, pregnancy test, sleep log
Visit 2-- sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG
Visit 3-- remove EEG, beginning of treatment with Bioboosti device, sleep log Treatment phase-- subjects use the Bioboosti at home for two weeks
Visit 4-- return of Bioboosti, sleep questionnaires, urine test for hormones associated with sleep, sleep log, placement of EEG
Visit 5-- remove EEG, collect sleep logs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioboosti | Experimental | Treatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time. |
|
| Sustained Efficacy | Experimental | Treatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia. Subjects will use it once a day for about one hour, before habitual sleep time. |
|
| Insomnia and migraine | Experimental | Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bioboosti | Device | Subjects will place the device on the palm of their hand for 8 minutes. There is a light on the device that changes to indicate that the 8 minutes have passed. They will then place it on the palm of the other hand and keep it there for 8 minutes. Alternating 8-minute cycles between hands will be done up to 6 times. |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | Change in Insomnia Severity Index (ISI) will be measured. The Insomnia Severity Index (ISI) is a short, 7-item self-report questionnaire used to screen for insomnia, assess its severity, and monitor treatment effectiveness by evaluating sleep problems (like falling/staying asleep, early waking) and their impact on daytime functioning over the past two weeks. Scoring from 0 to 28, with higher scores indicating greater severity, the ISI helps classify insomnia as none, subthreshold, moderate, or severe, guiding clinical decisions in research and practice. This will be done before and after treatment. | Baseline to 2 weeks |
| Pittsburgh Sleep Quality Index | The change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 2 weeks will be measured. The PSQI is a widely used, self-rated questionnaire that assesses sleep quality and disturbances over a one-month period. It consists of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), which are summed to yield a global score ranging from 0 to 21. Higher global scores indicate worse sleep quality. Change will be calculated as the PSQI score at 2 weeks minus the PSQI score at baseline (Week 2 - Baseline). Because lower PSQI scores indicate better sleep quality, a negative change score reflects an improvement in sleep quality, whereas a positive change score reflects worsening sleep quality. | Baseline to 2 weeks |
| Daytime Sleepiness | Daytime sleepiness will be assessed using a Visual Analog Scale (VAS) from baseline to 2 weeks. The VAS is a subjective measure consisting of a 100 mm horizontal line anchored by "not at all sleepy" (0 mm) on the left and "extremely sleepy" (100 mm) on the right. Participants mark the point on the line that best represents their current level of daytime sleepiness. Higher scores indicate greater sleepiness. Change will be calculated as the VAS score at 2 weeks minus the VAS score at baseline (Week 2 - Baseline). Because higher scores indicate greater sleepiness, a negative change score reflects a reduction in daytime sleepiness (improvement), whereas a positive change score reflects an increase in daytime sleepiness (worsening). The mean change and standard deviation of the change scores will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Milena Pavlova, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Brigham and Women's Faulkner Hospital |
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Bioboosti arm was only arm to enroll. No participants were enrolled in the "sustained efficacy" or "insomnia and migraine arms" as seen in results section and study publication
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| ID | Title | Description |
|---|---|---|
| FG000 | Bioboosti | Treatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time. |
| FG001 | Sustained Efficacy | Treatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia. Subjects will use it once a day for about one hour, before habitual sleep time. |
| FG002 | Insomnia and Migraine | Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Of 202 subjects who expressed interest, 20 subjects were enrolled in the study and 17 completed all component including both baseline and post-treatment ambulatory sleep EEG, and all questionnaires and wrist actigraphy.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bioboosti | Treatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time. |
| BG001 | Sustained Efficacy |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Insomnia Severity Index | Change in Insomnia Severity Index (ISI) will be measured. The Insomnia Severity Index (ISI) is a short, 7-item self-report questionnaire used to screen for insomnia, assess its severity, and monitor treatment effectiveness by evaluating sleep problems (like falling/staying asleep, early waking) and their impact on daytime functioning over the past two weeks. Scoring from 0 to 28, with higher scores indicating greater severity, the ISI helps classify insomnia as none, subthreshold, moderate, or severe, guiding clinical decisions in research and practice. This will be done before and after treatment. | Study only managed to progress to Bioboosti Arm, and not the other arms. Of the 20 enrolled patients, only 17 completed all necessary testing and were therefore included in data analysis. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to 2 weeks |
|
From enrollment until end of follow-up. This is around 2 weeks while the subjects were receiving study treatment/intervention, until when they returned the devices at the end of the study.
While the study is minimal risk, all participants who provided data have been considered "at risk" as adverse event monitoring occurred during the period that they were receiving the intervention.
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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 | Bioboosti | Treatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time. Bioboosti: Subjects will place the device on the palm of their hand for 8 minutes. There is a light on the device that changes to indicate that the 8 minutes have passed. They will then place it on the palm of the other hand and keep it there for 8 minutes. Alternating 8-minute cycles between hands will be done up to 6 times. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Milena Pavlova, M.D. | Brigham and Women's Hospital | (617) 983-7580 | mpavlova@bwh.harvard.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 | Jun 4, 2018 | Aug 1, 2018 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 4, 2018 | Aug 1, 2018 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Subjects will complete the first arm of the study. Upon completion, the subjects will be offered enrollment into the next long term arm of the study (Sustained Efficacy).
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|
| Baseline to 2 weeks |
| Boston |
| Massachusetts |
| 02130 |
| United States |
Treatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia.
Subjects will use it once a day for about one hour, before habitual sleep time.
| BG002 | Insomnia and Migraine | Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Treatment with the Bioboosti device for two weeks. The device produces a pulsed micro-magnetic field. Subjects will use it once a day for about one hour, before habitual sleep time.
| OG001 | Sustained Efficacy | Treatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia. Subjects will use it once a day for about one hour, before habitual sleep time. |
| OG002 | Insomnia and Migraine | Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time. |
|
|
| Primary | Pittsburgh Sleep Quality Index | The change in the Pittsburgh Sleep Quality Index (PSQI) from baseline to 2 weeks will be measured. The PSQI is a widely used, self-rated questionnaire that assesses sleep quality and disturbances over a one-month period. It consists of 19 items that generate seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), which are summed to yield a global score ranging from 0 to 21. Higher global scores indicate worse sleep quality. Change will be calculated as the PSQI score at 2 weeks minus the PSQI score at baseline (Week 2 - Baseline). Because lower PSQI scores indicate better sleep quality, a negative change score reflects an improvement in sleep quality, whereas a positive change score reflects worsening sleep quality. | Study only managed to progress to Bioboosti Arm, and not the other arms. Of the 20 enrolled patients, only 17 completed all necessary testing and were therefore included in data analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 2 weeks |
|
|
|
| Primary | Daytime Sleepiness | Daytime sleepiness will be assessed using a Visual Analog Scale (VAS) from baseline to 2 weeks. The VAS is a subjective measure consisting of a 100 mm horizontal line anchored by "not at all sleepy" (0 mm) on the left and "extremely sleepy" (100 mm) on the right. Participants mark the point on the line that best represents their current level of daytime sleepiness. Higher scores indicate greater sleepiness. Change will be calculated as the VAS score at 2 weeks minus the VAS score at baseline (Week 2 - Baseline). Because higher scores indicate greater sleepiness, a negative change score reflects a reduction in daytime sleepiness (improvement), whereas a positive change score reflects an increase in daytime sleepiness (worsening). The mean change and standard deviation of the change scores will be reported. | Study only managed to progress to Bioboosti Arm, and not the other arms. Of the 20 enrolled patients, only 17 completed all necessary testing and were therefore included in data analysis. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to 2 weeks |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sustained Efficacy | Treatment with Bioboosti device for a year. In order to see if the device has sustained efficacy in treating insomnia. Subjects will use it once a day for about one hour, before habitual sleep time. Bioboosti: Subjects will place the device on the palm of their hand for 8 minutes. There is a light on the device that changes to indicate that the 8 minutes have passed. They will then place it on the palm of the other hand and keep it there for 8 minutes. Alternating 8-minute cycles between hands will be done up to 6 times. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Insomnia and Migraine | Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time. Bioboosti: Subjects will place the device on the palm of their hand for 8 minutes. There is a light on the device that changes to indicate that the 8 minutes have passed. They will then place it on the palm of the other hand and keep it there for 8 minutes. Alternating 8-minute cycles between hands will be done up to 6 times. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D001523 |
| Mental Disorders |
| >=65 years |
|