40 Participants Needed

Transcranial Electrical Stimulation for Sleep Deprivation

JD
TJ
Overseen ByThomas J Balkin, Ph.D.
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: U.S. Army Medical Research and Development Command
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 explores whether transcranial electrical stimulation (TES), a special type of brain stimulation, can improve sleep quality and performance during sleep deprivation. The treatment aims to increase slow-wave brain activity, believed to enhance sleep's restorative effects. Participants will receive either the actual TES treatment or a sham (fake) version for comparison. The study seeks healthy individuals who typically sleep 6 to 9 hours per night and do not engage in excessive caffeine consumption or regular napping. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on sleep enhancement.

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

The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that the use of products or drugs that cannot be safely discontinued during in-laboratory phases will be determined on a case-by-case basis by the study investigator.

What prior data suggests that transcranial electrical stimulation is safe for sleep deprivation studies?

Research has shown that transcranial electrical stimulation (TES) is generally safe. One study found TES to be safe and effective in improving memory and focus in sleep-deprived individuals, with no major safety concerns reported. Another review examined multiple studies and found that TES could influence brain activity during sleep, though effects varied. In summary, TES has been tested on both healthy individuals and patients, demonstrating safety and potential benefits for sleep and memory.12345

Why are researchers excited about this trial?

Researchers are excited about Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency because it offers a novel approach to addressing sleep deprivation, which is typically managed with medications like stimulants or behavioral therapies. Unlike these standard treatments, TES uses a non-invasive technique that directly applies electrical currents to the brain to enhance natural sleep rhythms. This method has the potential to improve cognitive performance and mood without the side effects often associated with traditional medications. Additionally, TES could offer immediate benefits during short sleep periods, which is particularly promising for situations requiring rapid recovery from sleep deprivation.

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

Research has shown that transcranial electrical stimulation (TES) at a slow frequency might enhance brain activity during sleep. One study found that TES increased slow-wave activity in the brain, which is linked to better recovery after sleep deprivation. Another study suggested that TES might aid memory improvement during sleep. Although the overall impact on sleep may be modest, TES shows promise in enhancing specific aspects like sleep quality and mental function. In this trial, some participants will receive TES at a slow oscillation frequency, while others will receive a sham treatment without TES. These findings suggest that TES could make sleep more restorative, especially when sleep is limited.24678

Who Is on the Research Team?

JD

John D. Hughes, CDR, MC, USN

Principal Investigator

Naval Medical Research Center

Are You a Good Fit for This Trial?

This trial is for individuals who understand the study protocol, consume less than 400 mg of caffeine daily, have a normal sleep pattern (6-9 hours), and do not use heavy alcohol or drugs. They must not have cardiovascular disease, habitual napping, psychiatric hospitalizations in the last 2 years, abnormal blood tests, or be pregnant. Smokers and those with neurological disorders are excluded.

Inclusion Criteria

I understand the study's requirements and passed a quiz on them.

Exclusion Criteria

You sleep on average less than 6 hours or more than 9 hours per night.
You take naps more than once a week as part of your regular sleep schedule.
It takes you more than 20 minutes to fall asleep.
See 32 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 hours
1 visit (in-person)

At-home component

Participants complete a 7-day at-home component prior to the in-laboratory study

7 days

In-laboratory study period

Participants undergo TES SO or sham stimulation during a 2-hour sleep period followed by 46 hours of sleep deprivation with cognitive and mood assessments

138 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 days

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Electrical Stimulation (TES) at Slow Oscillation (SO) Frequency
Trial Overview The study is testing if transcranial electrical stimulation (TES) at slow oscillation frequency during nocturnal sleep can enhance sleep's restorative properties and improve performance after sleep deprivation. Participants will receive either actual TES using NeuroConn DC Stimulator PLUS or a sham treatment to compare effects.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Subjects Who Received TES SOExperimental Treatment1 Intervention
Group II: Received SHAM (no TES SO)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

U.S. Army Medical Research and Development Command

Lead Sponsor

Trials
296
Recruited
249,000+

Walter Reed Army Institute of Research (WRAIR)

Collaborator

Trials
111
Recruited
108,000+

Citations

The Effect of Transcranial Electrical Stimulation on ...The data show that TDCS can significantly improve EEGs and facial expressions post-acute SD; for example, compared to natural sleep recovery, ...
Systematic Review and Meta-analysis of the Effects ...Although tES does not appear to have a substantial overall effect on sleep, tACS may improve total sleep time, and pre-sleep offline tES may prolong sleep ...
Transcranial Electrical Stimulation (TES) at Slow ...The purpose of this study is to determine if the enhancement of electroencephalographic (EEG) slow-wave activity using transcranial electrical stimulation ...
Transcranial electrical stimulation during sleep enhances ...A meta-analysis examined whether transcranial electric stimulation (TES) administered during sleep can modulate memory consolidation.
A randomized study on the effect of a wearable device ...Our study identifies a new potential treatment for sleep onset insomnia that is comparably effective to current state-of-practice options.
Effect of the anodal transcranial direct current electrical ...a-tDCS appears safe and improves working memory, attention, response time and distractors elimination in acute sleep deprived medical residents.
The Effects of Transcranial Electrical Stimulation ...Forty studies were selected including 511 healthy participants and 452 patients. tES can modify endogenous brain oscillations during sleep. Results concerning ...
The Effect of Transcranial Electrical Stimulation on ...The data show that TDCS can significantly improve EEGs and facial expressions post-acute SD; for example, compared to natural sleep recovery, ...
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