Bioboosti Device for Insomnia

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Sleep apnea, Cancer, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the Bioboosti device improves sleep in people with insomnia. The device uses a pulsed micro-magnetic field and is applied once a day for about an hour before sleep. Participants are divided into different groups: one uses the device for two weeks, another for a year to assess lasting effects, and another includes individuals with both insomnia and migraines. Those with insomnia, but without untreated sleep apnea or major heart or kidney issues, may find this trial suitable. As an unphased trial, this study provides a unique opportunity to explore a novel approach to enhancing sleep quality.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Bioboosti device is safe for treating insomnia?

Research has shown that the Bioboosti device is easy to use and doesn't cause major side effects. In one study, users reported no significant problems and noted improved sleep after using it. Another study confirmed these findings, demonstrating the device's effectiveness and user-friendliness. This evidence suggests that the Bioboosti device offers a safe way to treat insomnia without unwanted effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bioboosti device for insomnia because it uses a pulsed micro-magnetic field, a novel approach compared to traditional treatments like medications or cognitive behavioral therapy. Unlike pills, which can have side effects or lead to dependency, the Bioboosti device is non-invasive and drug-free. Additionally, it offers a new delivery method by being a wearable device that users can incorporate into their nightly routine, potentially providing relief with consistent use. This innovative mechanism and user-friendly design are what make the Bioboosti device stand out in the pursuit of effective insomnia treatments.

What evidence suggests that the Bioboosti device is effective for insomnia?

Research has shown that the Bioboosti device might help people with insomnia. In earlier studies, users of Bioboosti reported significantly better sleep. For instance, one study found that after two weeks of using the device, the average sleep quality score improved from 13.5 to 8.4, marking a substantial improvement. In this trial, participants will be assigned to different treatment arms to evaluate the device's effectiveness over varying durations. The Bioboosti device creates a gentle magnetic field, which is thought to relax the mind and improve sleep. While more research is needed, these early results suggest Bioboosti could be a useful tool for better sleep without medication. ^{1 2 4 6 7}

Who Is on the Research Team?

Milena Pavlova, MD

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Consent form, physical exam, vitals, pregnancy test, sleep log, sleep questionnaires, urine test for hormones, placement of EEG

1 week

2 visits (in-person)

Treatment

Participants use the Bioboosti device at home for two weeks, once a day for about one hour before habitual sleep time

2 weeks

1 visit (in-person)

Post-Treatment Assessment

Return of Bioboosti, sleep questionnaires, urine test for hormones, sleep log, placement and removal of EEG

1 week

2 visits (in-person)

Follow-up

Participants are monitored for sustained efficacy and safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bioboosti Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Sustained Efficacy Experimental Treatment 1 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 migraine Experimental Treatment 1 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: Bioboosti Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Biomobie

Collaborator

Trials

1

Recruited

20+

Harvard University

Collaborator

Trials

237

Recruited

588,000+

Published Research Related to This Trial

The EU council directives provide a comprehensive regulatory framework to ensure the safety of biotechnological medicinal products, focusing on benefit/risk evaluation and quality assessment.

The framework emphasizes the importance of preclinical safety and efficacy testing before new drug applications are approved, ensuring that new treatments are both safe and effective for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of biotechnological products. Bass, R., Purves, J., Amati, MP.[2019]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is strongly recommended as the first-line treatment for chronic insomnia in adults, supported by high-quality evidence from systematic reviews.

Pharmacological treatments, such as benzodiazepines and certain antidepressants, can be used for short-term relief of insomnia, but other options like antihistamines and complementary therapies are not recommended due to low-quality evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guideline for the diagnosis and treatment of insomnia. Riemann, D., Baglioni, C., Bassetti, C., et al.[2022]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6748315/

Novel non-pharmacological insomnia treatment – a pilot ... After 2 weeks of treatment with BioBoosti, subjects reported significant improvements in several insomnia measures (Figure 1), including a ...

2. academic.oup.com academic.oup.com/sleep/article/41/suppl_1/A149/4988428

The Efficacy Of Bioboosti 8 Minute Electromagnetic Cycles For ... After 2 weeks of BioBoosti use, subjects reported improved sleep quality (PSQI: before, 13.5 ± 3.1 versus after, 8.4 ± 3.9, p=0.001) and reduced ...

3. neurology.org neurology.org/doi/10.1212/WNL.90.15_supplement.P1.110

The Efficacy of BioBoosti 8 Minute Electromagnetic Cycles ... After 2 weeks of BioBoosti use, subjects reported improved sleep quality (PSQI: before, 13.5 ± 3.4 versus after, 8.5 ± 4.0, p=0.003) and reduced ...

4. withpower.com withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-8-2016-169cc

Bioboosti Device for Insomnia · Info for Participants This trial is testing the Bioboosti device, a gadget to help people with insomnia sleep better without medication.

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/16/NCT02924116/Prot_SAP_001.pdf

Use of Bioboosti Non-pharmacologic Device for Insomnia ... We propose a pilot study to assess the effectiveness of FDA approved Biomobie device (Bioboosti) for the treatment of insomnia. RESEARCH DESIGN AND METHODS.

6. ctv.veeva.com ctv.veeva.com/study/bioboosti-device-for-insomnia-treatment

Bioboosti Device for Insomnia Treatment - ClinicalTrials.Veeva The purpose of this study is to determine the effects of the Bioboosti device on sleep for patients who have been diagnosed with insomnia.

7. trial.medpath.com trial.medpath.com/clinical-trial/440449f7e2dd7b88/nct02924116-use-bioboosti-device-insomnia-treatment

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