Bioboosti Device for Insomnia Treatment

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02924116

Collaborator

Biomobie (Other), Harvard University (Other)

Enrollment

Locations

Arms

Duration (Months)

10.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Device: Bioboosti	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

21 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention 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).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)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: 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.
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.	Device: 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.
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.	Device: 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.

Arm

Intervention/Treatment

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.

Device: 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.

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.

Device: Bioboosti

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.

Device: Bioboosti

Outcome Measures

Primary Outcome Measures

Change in Insomnia symptoms before treatment to after treatment [Week 1, Week 4]
Within subject comparisons before and after treatment, subjects answer questions on their sleep habits.
Change in Sleepiness before treatment to after treatment [Week 1, Week 4]
Within subject comparisons before and after treatment, subjects answer questions on sleep difficulty.

Secondary Outcome Measures

Change in EEG from before treatment to after treatment [Week 2, Week 4]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Brigham and Women's Faulkner Hospital	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

Brigham and Women's Hospital
Biomobie
Harvard University

Investigators

Principal Investigator: Milena Pavlova, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

Pavlova, Milena,M.D., Medical Doctor, Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT02924116

Other Study ID Numbers:

2016P000996

First Posted:

Oct 5, 2016

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Pavlova, Milena,M.D., Medical Doctor, Brigham and Women's Hospital

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Study Results

No Results Posted as of Mar 2, 2022