Brain Stimulation for Insomnia
(SS_Sleep Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how transcranial electrical stimulation (tES), a type of brain stimulation, can aid in falling asleep and improving sleep quality. The goal is to determine if this gentle electrical treatment can facilitate easier sleep onset and maintenance. The trial seeks participants who experience insomnia but do not have other serious medical conditions such as epilepsy or migraines. Those who have had trouble sleeping and wish to try a new approach may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative sleep solutions without the constraints of traditional clinical trial phases.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators.
What prior data suggests that this brain stimulation technique is safe for improving sleep quality?
Research has shown that transcranial electrical stimulation (tES), which uses small electrical currents on the brain, has been explored for its impact on sleep. Results from studies are mixed regarding its effects on sleep patterns, but it is generally considered safe. For instance, one study found that tES can improve sleep and reduce daytime sleepiness. Another study showed that tES is as effective as current treatments for insomnia.
Overall, while tES may help with some sleep issues, it is well-tolerated, and no major safety concerns have been reported in these studies.12345Why are researchers excited about this trial?
Transcranial Electrical Stimulation (tES) is unique because it offers a non-invasive way to address insomnia by gently sending electrical currents to specific areas of the brain. Unlike traditional treatments like medications or cognitive behavioral therapy, which can take weeks to show effects, tES has the potential to work more quickly by directly influencing brain activity. Researchers are excited about this treatment because it could provide a faster, drug-free alternative with fewer side effects, making it a promising option for those struggling with sleep issues.
What evidence suggests that transcranial electrical stimulation is effective for insomnia?
Research has shown that transcranial electrical stimulation (tES), which participants in this trial will receive, might help people with insomnia sleep better. For example, one study found that tES reduced the time it took for participants to fall asleep by 53% compared to before treatment. Another study suggested that tES could be effective for chronic insomnia over an eight-week period. Although the exact mechanism of tES in the brain remains unclear, these findings suggest it could be a promising way to improve sleep quality.34678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 who have trouble sleeping. It's not suitable for individuals with epilepsy, serious head injuries, brain surgery history, metal implants in the head, pacemakers or other implanted devices, those who are pregnant, have a history of seizures or migraines, or any severe medical condition besides insomnia.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive targeted brain stimulation using tES and/or EEG to assess effects on sleep onset and quality
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Transcranial Electrical Stimulation (tES)
Find a Clinic Near You
Who Is Running the Clinical Trial?
StimScience Inc.
Lead Sponsor