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Bioboosti Device for Insomnia

N/A
Waitlist Available
Led By Milena Pavlova, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, week 4
Awards & highlights

Study Summary

This trial will test whether the Bioboosti device can improve sleep for people with insomnia.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Potential side effects of using the Bioboosti device are not detailed in the provided information. Typically such devices may cause discomfort at site of application or skin irritation but specific side effects would depend on how the device functions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Insomnia symptoms before treatment to after treatment
Change in Sleepiness before treatment to after treatment
Secondary outcome measures
Change in EEG from before treatment to after treatment

Trial Design

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.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,599 Previous Clinical Trials
11,462,493 Total Patients Enrolled
12 Trials studying Insomnia
40,951 Patients Enrolled for Insomnia
BiomobieUNKNOWN
Harvard UniversityOTHER
229 Previous Clinical Trials
474,588 Total Patients Enrolled
1 Trials studying Insomnia
1,500 Patients Enrolled for Insomnia

Media Library

Bioboosti Device (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02924116 — N/A
Insomnia Research Study Groups: Bioboosti, Sustained Efficacy, Insomnia and migraine
Insomnia Clinical Trial 2023: Bioboosti Device Highlights & Side Effects. Trial Name: NCT02924116 — N/A
Bioboosti Device (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02924116 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative open to individuals aged 45 and above?

"According to the prerequisites for this research, participants must be 18 years old or older and no more than 65."

Answered by AI

Is the recruitment of patients still ongoing for this clinical investigation?

"According to information found on clinicaltrials.gov, this trial is no longer actively enrolling patients at the present time. The study was initially posted in September 2016 and updated most recently during February 2022. Although this particular research is not recruiting currently, there are 228 other studies that require participants now."

Answered by AI

Is it possible for me to join this medical research study?

"Candidates meeting the age requirement of 18 to 65 years old, and suffering from insomnia, may be eligible for this research trial. Approximately 21 patients are being accepted into the study."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Brigham and Women's Faulkner Hospital
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have seen.
PatientReceived 1 prior treatment
~0 spots leftby Jun 2024