Bioboosti Device for Insomnia Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment: A Pilot Study

Conditions
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Insomnia

Intervention / Treatment
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* Device: Bioboosti


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioboosti<br>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. | Device: Bioboosti<br>* 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.<br>|
| Experimental: Sustained Efficacy<br>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. | Device: Bioboosti<br>* 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.<br>|
| Experimental: Insomnia and migraine<br>Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time. | Device: Bioboosti<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Insomnia symptoms before treatment to after treatment | Within subject comparisons before and after treatment, subjects answer questions on their sleep habits. | Week 1, Week 4 | 
| Change in Sleepiness before treatment to after treatment | Within subject comparisons before and after treatment, subjects answer questions on sleep difficulty. | Week 1, Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in EEG from before treatment to after treatment | 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. | Week 2, Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, insomnia, Bioboosti, Biomobie, device