Bioboosti Device for Insomnia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMilena Pavlova, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the Bioboosti device, a gadget to help people with insomnia sleep better without medication. The study involves patients diagnosed with insomnia to see if this device can improve their sleep quality. The Bioboosti device has been previously tested, showing improved sleep quality and reduced insomnia symptoms after a short period of use.

Eligibility Criteria

This trial is for individuals who have insomnia. It's not suitable for those with untreated sleep apnea, major circadian rhythm disorders, pregnant or breastfeeding women, people with pacemakers or severe heart, brain, kidney or blood conditions; cancer patients; recent bypass graft recipients; those with acute heart failure, renal insufficiency or intestinal obstruction.

Inclusion Criteria

I have trouble sleeping.

Exclusion Criteria

Breastfeeding

I have had cancer in the past.

I do not have severe heart, brain, kidney, or blood conditions.

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Treatment Details

Interventions

Bioboosti Device (Other)

Trial OverviewThe study is testing the Bioboosti device to see if it helps improve sleep in patients with insomnia. Participants will use this device and their sleep patterns will be monitored to assess its effectiveness.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Sustained EfficacyExperimental Treatment1 Intervention

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.

Group II: Insomnia and migraineExperimental Treatment1 Intervention

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

Group III: BioboostiExperimental Treatment1 Intervention

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.