Bioboosti Device for Insomnia

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

21 Participants Needed

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.

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 data supports the effectiveness of the Bioboosti Device treatment for insomnia?

The pilot study on the Bioboosti Device suggests it may help with insomnia symptoms in adults. Additionally, a study on a similar sleep-enhancing device, the Somnox sleep robot, showed mixed results but indicated that such devices are generally safe and acceptable for adults with insomnia. ^{1 2 3 4 5}

Is the Bioboosti Device safe for humans?

The safety of biotechnological products, like the Bioboosti Device, is evaluated through guidelines that assess potential effects on the heart, brain, and lungs before they are tested in humans. This ensures that any undesirable effects are identified early, making the process safer for participants. ^{6 7 8 9 10}

How does the Bioboosti Device treatment for insomnia differ from other treatments?

The Bioboosti Device is a novel non-drug treatment for insomnia that does not rely on medication, making it unique compared to traditional pharmacological options. It offers a non-pharmacological approach, which may appeal to those seeking alternatives to medication-based treatments. ^{1 2 3 4 11}

Research Team

Milena Pavlova, MD

Principal Investigator

Brigham and Women's Hospital

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Novel non-pharmacological insomnia treatment - a pilot study. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Technically sleeping? A clinical single-case study of a commercial sleep robot. [2023]

3. England pubmed.ncbi.nlm.nih.gov

European guideline for the diagnosis and treatment of insomnia. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of vestibular stimulation in a four-hour sleep phase advance model of transient insomnia. [2021]

5. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Digital Insomnia Treatment with Adjunctive Wearable Technology: A Pilot Randomized Controlled Trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The patient alert system--pilot study of built-in warning systems for pacemakers. [2019]

8. Denmark pubmed.ncbi.nlm.nih.gov

Safety of biotechnological products. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Safety Pharmacology Evaluation of Biopharmaceuticals. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial. [2015]

11. Scotland pubmed.ncbi.nlm.nih.gov

A novel taping therapy for chronic insomnia: a report on two cases. [2013]