Bioboosti Device for Insomnia Treatment
Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment: A Pilot Study
Study Overview
Detailed Description
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, United States, 02130
- Brigham and Women's Faulkner Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with insomnia
Exclusion Criteria:
- Untreated moderate or severe sleep apnea
- Major circadian rhythm disorder
- Pregnant women
- Breastfeeding
- Cardiac pacemaker
- Cancer
- Severe conditions related to heart, brain, kidney and hematopoietic system
- Severe/unstable angina pectoris
- Arteria coronaria/ peripheral arterial bypass graft
- Acute congestive heart failure
- Renal insufficiency
- Mechanical intestinal obstruction
- Any electrical devices
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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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Experimental: 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. |
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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Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Insomnia Severity Index
Time Frame: Baseline to 2 weeks
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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.
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Baseline to 2 weeks
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Pittsburgh Sleep Quality Index
Time Frame: Baseline to 2 weeks
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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.
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Baseline to 2 weeks
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Daytime Sleepiness
Time Frame: Baseline to 2 weeks
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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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Baseline to 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in EEG from before treatment to after treatment
Time Frame: Week 2, Week 4
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Ambulatory EEG will be used before treatment and after treatment, using sleep montage per standard AASM criteria and scored by a registered polysomnography technologist using AASM guidelines.
Sleep architecture will be reported as the percent of time the subject remains in the different sleep stages.
Specifically we will compare percent in REM sleep before and after treatment.
The waveform of the EEG that will be assessed during teh study period is delta.
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Week 2, Week 4
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Milena Pavlova, MD, Brigham and Women's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016P000996
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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