55 Participants Needed

Electrical Stimulation for Sleep and Emotional Health

SG
Overseen ByStephanie G Jones
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications that can affect seizure thresholds, such as ADHD stimulants, some antidepressants, antipsychotics, bronchodilators, certain antibiotics, antivirals, and some over-the-counter antihistamines.

What data supports the effectiveness of the treatment Transcranial electrical stimulation with Temporal Interference (TES-TI) for sleep and emotional health?

Research shows that transcranial electrical stimulation (TES) can improve sleep quality and reduce the time it takes to fall asleep. Additionally, TES has been found to have positive effects on depression and anxiety, suggesting it may help with emotional health.12345

Is electrical stimulation for sleep and emotional health safe for humans?

Research shows that low-intensity transcranial electrical stimulation (TES), including various forms like TES-TI, is generally safe for humans. No serious adverse effects have been reported in over 18,000 sessions, and mild effects like headaches or skin sensations are rare. Studies also found no significant safety concerns with temporal interference stimulation in healthy adults.16789

How does electrical stimulation differ from other treatments for sleep and emotional health?

Electrical stimulation, specifically transcranial electrical stimulation (tES) and cranial electrotherapy stimulation, is unique because it uses non-invasive, mild electrical currents to modulate brain activity, potentially improving sleep and emotional health without the side effects associated with sedative drugs. Unlike traditional medications, this approach can be personalized to an individual's brain activity patterns, offering a tailored treatment option.12101112

What is the purpose of this trial?

The goal of this clinical trial is to find out whether stimulating the brain with electrical current during naps can increase certain kinds of brain activity that happen during sleep and lead to improvements in emotional health and stress resilience.Participants will attend up to 3 study visits, each of which may last up to 4-5 hours. During these visits, participants will wear a high density electroencephalography (hdEEG) cap and take a nap.

Research Team

GT

Giulio Tononi, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for healthy, English-speaking adults aged 18-50 who are regular nappers and either citizens or permanent residents. It's not suitable for those with a history of significant head trauma, neurological disorders, metal in the body, seizures, certain medical conditions or devices, dental implants with metal, claustrophobia, night-shift workers, back issues preventing lying flat or unstable medical conditions.

Inclusion Criteria

Citizen or holding permanent resident status
I am in good health.
English-speaking (able to provide consent and complete questionnaires)
See 1 more

Exclusion Criteria

I have had a severe head injury or more than 3 mild concussions.
I suffer from severe headaches or migraines that are hard to control.
I have no history of neurological disorders or brain injuries.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I

Participants undergo multiple naps with varied parameters to identify optimal conditions for enhancing REM sleep

Varies per participant
Multiple visits

Phase II

Participants undergo two 90-minute naps with sham or non-sham stimulation conditions, completing questionnaires and emotion regulation tasks

2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for changes in sleep quality, mood, and emotional response

4 weeks

Treatment Details

Interventions

  • Transcranial electrical stimulation with Temporal Interference (TES-TI)
Trial Overview The study tests if brain stimulation using Transcranial electrical stimulation with Temporal Interference (TES-TI) during naps can enhance sleep-related brain activity and improve emotional health and stress resilience. Participants will have up to three visits involving wearing an hdEEG cap while taking a nap.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Stimulation followed by no stimulationExperimental Treatment1 Intervention
Phase 2 participants will receive stimulation during their nap at the first visit, and no stimulation during their nap at the second visit.
Group II: No stimulation followed by stimulationExperimental Treatment1 Intervention
Phase 2 participants will not receive stimulation during their nap at the first visit, and receive stimulation during their nap at the second visit.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Findings from Research

Transcranial Electrical Stimulation (tES) has been shown to modify brain oscillations during sleep, indicating its potential as a non-invasive tool for sleep modulation.
While the effects of tES on objective sleep patterns are inconsistent, subjective assessments of sleep quality consistently show improvements, suggesting that tES may enhance perceived sleep quality in both healthy individuals and patients.
The Effects of Transcranial Electrical Stimulation of the Brain on Sleep: A Systematic Review.Dondé, C., Brunelin, J., Micoulaud-Franchi, JA., et al.[2021]
A study involving 25 participants showed that personalized transcranial alternating current stimulation (tACS) significantly increased sleep duration by an average of 22 minutes compared to a control condition, highlighting its potential as a non-invasive sleep intervention.
Personalized tACS also reduced the time taken to fall asleep by 28% compared to fixed stimulation, suggesting that tailoring stimulation to individual brain activity may enhance sleep quality, especially for those with insomnia.
Personalized transcranial alternating current stimulation improves sleep quality: Initial findings.Ayanampudi, V., Kumar, V., Krishnan, A., et al.[2023]
Transcranial electrical stimulation (TES) can modulate brain activity using low-intensity currents, but the effects observed may not solely be due to the targeted brain region, as peripheral stimulation could also play a significant role.
The review emphasizes the need for careful consideration of TES's biophysical properties and dose-response relationships, suggesting that researchers should control for peripheral effects and be cautious in attributing behavioral changes to specific brain areas.
Can Transcranial Electrical Stimulation Localize Brain Function?Karabanov, AN., Saturnino, GB., Thielscher, A., et al.[2023]

References

The Effects of Transcranial Electrical Stimulation of the Brain on Sleep: A Systematic Review. [2021]
Personalized transcranial alternating current stimulation improves sleep quality: Initial findings. [2023]
Can Transcranial Electrical Stimulation Localize Brain Function? [2023]
The efficacy of non-invasive, non-convulsive electrical neuromodulation on depression, anxiety and sleep disturbance: a systematic review and meta-analysis. [2022]
[The effect of transcranial direct current stimulation on dysfunction of bilateral posterior cingulate cortex after sleep deprivation: a preliminary study]. [2020]
Tolerability of Repeated Application of Transcranial Electrical Stimulation with Limited Outputs to Healthy Subjects. [2018]
Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]
Safety Evaluation of Employing Temporal Interference Transcranial Alternating Current Stimulation in Human Studies. [2022]
Blinding efficacy and adverse events following repeated transcranial alternating current, direct current, and random noise stimulation. [2022]
The Efficacy of Transcranial Current Stimulation Techniques to Modulate Resting-State EEG, to Affect Vigilance and to Promote Sleepiness. [2020]
Efficacy of cranial electrotherapy stimulation on mood and sense of well-being in people with subclinical insomnia. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Cranial electrotherapy stimulation for treatment of anxiety, depression, and insomnia. [2022]
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