What side effects are associated with this type of intervention?

Common treatments for insomnia include pharmacological options like benzodiazepines and non-benzodiazepine hypnotics, which can cause side effects such as daytime drowsiness, dizziness, headache, and potential dependency. Cognitive-behavioral therapy (CBT) is generally safe but may temporarily increase anxiety or stress. Device-based treatments, similar to the Bioboosti device, may cause discomfort or irritation from device use. Always consult with a healthcare provider to determine the most appropriate treatment and manage any potential side effects.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for insomnia, including benzodiazepines (e.g., temazepam), non-benzodiazepine hypnotics (e.g., zolpidem, eszopiclone), melatonin receptor agonists (e.g., ramelteon), and orexin receptor antagonists (e.g., suvorexant). These medications work through various mechanisms such as enhancing GABA activity, modulating melatonin receptors, or inhibiting orexin receptors to promote sleep. While the Bioboosti device's mechanism is not specified, these pharmacologic treatments represent the primary FDA-approved options for managing insomnia.

What other types of research exist?

Promising novel alternatives to the Bioboosti device for treating insomnia in 2024 include: 1) Auricular Vagus Nerve Stimulation (aVNS), which uses personalized electroceuticals and biofeedback for optimized therapy; 2) Optoacoustic neural stimulation, which offers high-precision neuromodulation; and 3) Implantable bioelectronic devices that provide chronic neural interfacing and stimulation. These alternatives leverage advanced bioelectronics and neural modulation techniques to potentially improve sleep quality in insomnia patients.

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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

Must not have

History of cancer

Untreated moderate or severe sleep apnea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, week 4

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had cancer in the past.

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I have moderate to severe sleep apnea that hasn't been treated.

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

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I have a blockage in my intestines.

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I have severe chest pain due to heart problems.

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I have been diagnosed with sudden onset heart failure.

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I have kidney problems.

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I have had a heart or leg artery bypass surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, week 4

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Insomnia symptoms before treatment to after treatment

Change in Sleepiness before treatment to after treatment

Secondary study objectives

Change in EEG from before treatment to after treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for insomnia work through various mechanisms to improve sleep quality. Pharmacological treatments like melatonin help regulate the sleep-wake cycle, while benzodiazepine receptor agonists (BZRAs) enhance GABA activity to promote sleep. Non-pharmacological treatments such as cognitive behavioral therapy for insomnia (CBT-I) target the thoughts and behaviors that interfere with sleep, and light therapy helps reset the circadian rhythm. Understanding these mechanisms is crucial for insomnia patients as it allows for tailored treatment plans that address specific underlying issues, potentially leading to more effective and sustainable improvements in sleep.

Cognitive behavioral treatment for insomnia is equally effective in insomnia patients with objective short and normal sleep duration.