BTL-699-2 for Sleep Quality

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BTL Industries Ltd.

Must not be taking: Prescription sleep meds

Disqualifiers: Seizures, Heart disorders, Tumors, others

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

Compensation: Varies

Number of Visits: 8

Duration: 3-6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the BTL-699-2 device can improve sleep quality and reduce stress in adults. It uses transcranial magnetic stimulation, a technique that employs magnetic fields to stimulate the brain, to achieve these goals. Participants will be divided into two groups: one will receive the actual treatment, while the other will receive a very low-intensity version for comparison. This trial suits adults over 22 with ongoing sleep issues who do not heavily rely on sleep medications. Participants must complete various questionnaires about their sleep and stress levels during the trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance sleep and stress management for many.

Will I have to stop taking my current medications?

The trial requires that you stay on your current prescribed medications at a stable dose for at least 2 months before joining. However, you cannot use prescription sleep medications or certain over-the-counter sleep aids frequently.

What prior data suggests that the BTL-699-2 device is safe for improving sleep quality and reducing stress?

Research has shown that transcranial magnetic stimulation (TMS), as used in the BTL-699-2 device, is generally safe for healthy individuals and those with certain conditions. TMS uses magnetic fields to stimulate brain cells, and most people tolerate it well.

Some individuals might experience mild side effects, such as headaches or slight discomfort during treatment, which usually resolve quickly. Serious side effects are uncommon in healthy individuals.

Since the BTL-699-2 device employs this technology, it is expected to be similarly safe. However, discussing any concerns with a doctor before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about BTL-699-2 for improving sleep quality because it offers a new approach compared to traditional treatments like medication or cognitive behavioral therapy. Unlike these standard methods, BTL-699-2 uses transcranial magnetic stimulation, which is a non-invasive technique that directly targets brain activity related to sleep. This method has the potential to improve sleep without the side effects often associated with medications, making it a promising alternative for those struggling with sleep issues. The unique mechanism of using magnetic fields to influence brain function sets it apart from current options and opens new possibilities for effective sleep interventions.

What evidence suggests that the BTL-699-2 device is effective for improving sleep quality?

Studies have shown that sleep quality improves after using transcranial magnetic stimulation (TMS), the technology behind the BTL-699-2 device. One study demonstrated that participants experienced better sleep, as indicated by a significant improvement in their Pittsburgh Sleep Quality Index (PSQI) scores. The research also found a positive connection between improved sleep and reduced symptoms of depression. In this trial, participants in Group A will receive active TMS treatment with the BTL-699-2 device, while Group B will receive a sham treatment. Although the BTL-699-2 device is designed to enhance sleep and reduce stress, these findings support its potential effectiveness for sleep problems. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults over the age of 22 who are looking to improve their sleep quality and reduce stress may be eligible for this trial. Specific eligibility criteria have not been provided, but typically participants must meet certain health conditions.

Inclusion Criteria

Ability to maintain regular diet and exercise regimen without significant change

Compliance with study instructions and clinic visits

Women of child-bearing potential to use birth control measures

Exclusion Criteria

My treatment involves the heart area.

I do not have a history of severe mental health, brain disorders, or serious head injuries.

Suicidal tendencies, recent suicide attempt, concurrent use of electroconvulsive therapy or vagus nerve stimulation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive six treatments with the BTL-699-2 device, 3-7 days apart

3-6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 month and 3 months post-treatment

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BTL-699-2

Trial Overview The EXOMIND (BTL-699-2) trial is testing a device designed to enhance sleep and alleviate stress. Participants will receive six treatments with either the actual BTL-699-2 device or a sham (placebo) version, followed by various questionnaires assessing sleep and stress levels.

How Is the Trial Designed?

Group I: Group A - active Active Control 1 Intervention

Group A will receive transcranial magnetic stimulation treatment with the intensity of up to 70% of their motor treshold with the BTL-699-2 device.

Group II: Group B - sham Placebo Group 1 Intervention

Group B will receive transcranial magnetic stimulation treatment with the intensity of 5% of their motor treshold with the BTL-699-2 device.

Who Is Running the Clinical Trial?

BTL Industries Ltd.

Lead Sponsor

Trials

59

Recruited

2,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07027657

Study Details | NCT07027657 | EXOMIND (BTL-699-2) for ... The goal of this clinical trial is to evaluate whether the treatment with BTL-699-2 device is able to improve sleep quality and reduce stress in adults ...

2. withpower.com withpower.com/trial/phase-sleeping-quality-4-2025-897c3

BTL-699-2 for Sleep Quality The goal of this clinical trial is to evaluate whether the treatment with BTL-699-2 device is able to improve sleep quality and reduce stress in adults ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11456523/

Effect of sleep quality on repetitive transcranial magnetic ... We found that sleep quality improves after TMS (p<.001) and correlates with improvement in non-insomnia related depression symptoms (r= .318, p<.001).

4. ichgcp.net ichgcp.net/clinical-trials-registry/541379-exomind-btl-699-2-for-the-improvement-of-sleep-quality-and-reduction-of-stress

Study on BTL-699-2 for Better Sleep and Stress Relief This clinical trial explores the safety and effectiveness of a device called BTL-699-2 for improving sleep quality and reducing stress.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12447803/

Effectiveness of different repetitive transcranial magnetic ... A frequentist network meta-analysis was conducted to compare differences in the Pittsburgh Sleep Quality Index (PSQI) scores, sleep efficiency, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9753778/

Transcranial magnetic stimulation of the brain - PubMed Central Transcranial (electro)magnetic stimulation (TMS) is currently the method of choice to non-invasively induce neural activity in the human brain.

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1458696/epub

Effect of sleep quality on repetitive transcranial magnetic ... We aimed to explore whether baseline sleep quality, specifically insomnia, is associated with rTMS outcomes in a naturalistic sample of 975 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9094636/

Safety and recommendations for TMS use in healthy subjects ... Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines