Transcranial Electrical Stimulation for Sleep Enhancement

SP
Overseen BySean Prahl
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a gentle electrical current applied to the head during naps can boost brain activity related to sleep and help reduce mental fatigue. Participants will take naps on two different visits, with and without the electrical stimulation known as transcranial electrical stimulation with Temporal Interference (TES-TI). The trial seeks adults who feel their sleep is not refreshing and can take daytime naps. This might be suitable for those who feel tired during the day and do not have neurological or severe headache conditions.

As an unphased trial, this study offers a unique opportunity to explore innovative sleep enhancement techniques.

Will I have to stop taking my current medications?

You may need to stop taking certain medications that can affect seizure thresholds, like ADHD stimulants, some antidepressants, antipsychotics, bronchodilators, certain antibiotics, antivirals, and some over-the-counter antihistamines. It's best to discuss your specific medications with the study team.

What prior data suggests that this transcranial electrical stimulation technique is safe for sleep enhancement?

Research has shown that Transcranial Electrical Stimulation with Temporal Interference (TES-TI) is generally safe for people. One study found it to be a safe method for brain stimulation without surgery. Another study demonstrated that TES-TI can safely target specific brain areas.

So far, research has not identified any serious side effects. Most people tolerate the treatment well, though some might experience mild tingling or itching on the scalp where the electrodes are placed. Overall, TES-TI appears to be a safe option for brain stimulation.12345

Why are researchers excited about this trial?

Researchers are excited about the use of Transcranial Electrical Stimulation with Temporal Interference (TES-TI) for enhancing sleep because it offers a non-invasive approach to potentially improve sleep quality. Unlike traditional sleep aids like medications that can have side effects and lead to dependency, TES-TI uses electrical currents to specifically target brain regions involved in sleep regulation without physically penetrating the skull. This method could enable personalized sleep enhancement by adjusting the stimulation patterns, offering a new avenue for those who struggle with achieving restorative sleep.

What evidence suggests that transcranial electrical stimulation is effective for enhancing sleep?

Research has shown that enhancing slow-wave activity, a type of deep sleep, can boost brain performance. Studies have found that transcranial electrical stimulation with Temporal Interference (TES-TI) can increase this deep sleep activity. This trial will test TES-TI, with participants receiving stimulation during their nap at either the first visit or the second visit, but not both. Increased deep sleep activity is linked to better mental function and reduced tiredness. Participants who have used this stimulation demonstrated noticeable improvements in brain activity compared to those relying solely on natural sleep. Overall, these findings suggest that TES-TI might improve sleep quality and reduce mental fatigue.12456

Who Is on the Research Team?

GT

Guilio Tononi, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adults aged 25-75 who feel their sleep isn't refreshing, can nap during the day, and speak English. It's not for those with certain hairstyles that can't be removed, back issues preventing lying flat, head trauma history, seizure risks, possible pregnancy soon, metal in the head or medical implants like pacemakers.

Inclusion Criteria

I am between 25 and 75 years old.
I feel my sleep isn't refreshing.
Capable of taking daytime naps
See 1 more

Exclusion Criteria

Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions
I can lie flat without back pain for up to two hours.
I have had a severe head injury or more than 3 mild concussions.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend 2 study visits where they take naps with and without TES-TI stimulation

2 visits (each lasting 4-5 hours)
2 visits (in-person)

Follow-up

Participants are monitored for changes in slow waves and sleep quality from baseline to 1 month

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial electrical stimulation with Temporal Interference (TES-TI)
Trial Overview The study tests if brain stimulation with TES-TI during naps can enhance brain activity related to sleep and reduce mental fatigue. Participants will have two visits involving a nap while wearing an hdEEG cap to monitor brain waves.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Stimulation followed by no stimulationExperimental Treatment1 Intervention
Group II: No stimulation followed by stimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Corundum Convergence Institute

Collaborator

Citations

0468 Enhancement of Sleep Slow Waves Using Transcranial ...Disrupted SWA has been implicated in poor cognitive performance. Conversely, enhancement of slow waves has been shown to improve performance.
Enhancement of Sleep Slow Wave Activity using ...We performed simultaneous hd-EEG recording and Transcranial Electrical Stimulation with Temporal Interference (TES-TI, 15 kHz, 1 Hz difference) ...
The Effect of Transcranial Electrical Stimulation on the ...The data show that TDCS can significantly improve EEGs and facial expressions post-acute SD; for example, compared to natural sleep recovery, ...
Human Applications of Transcranial Temporal Interference ...Extracted data included bibliographic information, participant characteristics, study design, collected outcomes, stimulation parameters, and ...
a review of transcranial temporal interference stimulation ...This review systematically examines advancements in TI research from June 2017 to December 2024, encompassing safety evaluations, computational ...
Recommendations for the Safe Application of Temporal ...TIS is a new form of transcranial electrical stimulation (tES) that has been proposed as a method for targeted, non-invasive stimulation of deep brain ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security