Bioboosti Device for Insomnia Treatment

Mass General Brigham

Status: Completed

Conditions: Insomnia

Treatments: Device: Bioboosti

Study type: Interventional

Funder types: Other

Identifiers

NCT02924116

2016P000996

Details and patient eligibility

About

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

Full 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

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Bioboosti

Experimental group

Description:

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.

Treatment:

Device: Bioboosti

Sustained Efficacy

Experimental group

Description:

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.

Treatment:

Device: Bioboosti

Insomnia and migraine

Experimental group

Description:

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

Treatment:

Device: Bioboosti