Bioboosti Device for Insomnia Treatment

Not Applicable

• Conditions: Insomnia
• Interventions: Device: Bioboosti

• Registration Number: NCT02924116
• Lead Sponsor: Brigham and Women's Hospital

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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Bioboosti	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.
Sustained Efficacy	Bioboosti	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	Bioboosti	Treatment with the Bioboosti device for a month. Subjects will use it once a day for about one hour, before habitual sleep time.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Faulkner Hospital; 🇺🇸 Boston, Massachusetts, United States