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Transcranial Electric Stimulation for Sleep

(MTEC Phase 2 Trial)

YC
MT
Overseen ByMaria Tsimpanouli
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
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 evaluate how a special headband, the Wireless Interface Sensor Pod (WISP), can enhance brain function after poor sleep. The headband tracks brain waves and uses small electrical pulses to improve sleep quality and clear waste from the brain. Researchers seek to understand how different brain regions contribute to memory and how sleep impacts this process. Participants should be generally healthy, maintain a regular sleep pattern of 6 to 10 hours, and wake up between 5:00 and 9:00 AM. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research on sleep and brain health.

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

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking anti-psychotic medication for ADHD/ADD or using melatonin within one week of the study.

What prior data suggests that the Wireless Interface Sensor Pod (WISP) is safe for use in sleep studies?

Previous studies have shown that transcranial electrical stimulation (TES) is very safe. Research indicates that TES can be used repeatedly in humans without causing harmful side effects. A review of multiple studies found TES to be generally safe for healthy adults, even when used in several sessions, including for improving sleep. Across various trials, thousands have used TES with very few negative effects. While its effectiveness can vary, its safety remains consistently high, making it a well-tolerated option for those considering joining such trials.12345

Why are researchers excited about this trial?

Researchers are excited about the trial of Transcranial Electric Stimulation (TES) for sleep because it offers a new approach to improving sleep quality. Unlike traditional treatments like medications or behavioral therapies, TES uses a non-invasive method to directly stimulate the brain with electrical currents. This could potentially enhance sleep without the side effects often associated with sleep medications. The Wireless Interface Sensor Pod (WISP) makes this process wireless and convenient, providing a novel way to explore how TES can be integrated into daily life for better sleep management.

What evidence suggests that the Wireless Interface Sensor Pod (WISP) is effective for improving sleep and brain function?

This trial will evaluate the effects of transcranial electric stimulation (TES) on sleep. Participants will join different groups, including those with sleep restriction or normal sleep schedules, with or without active TES. Research has suggested that TES might improve sleep quality and duration. One study found that TES helped people sleep about 22 minutes longer than those without it. Another study showed that TES improved sleep quality and efficiency compared to a placebo treatment. However, not all studies agree, as some show no significant benefits. Overall, TES shows promise for improving sleep, but results can vary.56789

Who Is on the Research Team?

JI

Jeffrey Iliff, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for younger adults who are able to attend four in-person visits at the University of Washington Medical Center. Participants should be willing to wear a headband device during sleep, complete daily journals, and undergo MRI scans and memory tests.

Inclusion Criteria

Physically and psychologically healthy
Good habitual sleep between 6 and 10 hours in duration, as assessed by questionnaire and pre-study week sleep/wake diary
Regular bedtimes, habitually getting up between 05:00 and 09:00, as assessed by questionnaire and pre-study week sleep/wake diary

Exclusion Criteria

Subjects engaged in shift work within three months prior to study or during study participation, as assessed by questionnaire
Hearing-impaired subjects unless corrected to normal, as assessed by questionnaire
Pregnant subjects, as assessed by history and questionnaire
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 4 in-person study visits over 4 weeks, including MRI and cognitive testing, while using the WISP headband to monitor and improve slow wave sleep and glymphatic clearance.

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Wireless Interface Sensor Pod (WISP)

Trial Overview

The study compares the effects of transcranial electric stimulation (a mild electrical current delivered through a headband) versus no stimulation (sham) on brain waste clearance and memory after both normal and restricted sleep. Each participant experiences all conditions.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Sleep restriction, TESExperimental Treatment1 Intervention
Group II: Normal sleep, TESExperimental Treatment1 Intervention
Group III: Sleep restriction, no TESPlacebo Group1 Intervention
Group IV: Normal sleep, no TESPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Medical Technology Enterprise Consortium

Collaborator

Trials
3
Recruited
340+

Citations

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 ...

The Effects of Transcranial Electrical Stimulation of the Brain ...

Similarly, a crossover study that tested slow alternating tES during sleep found higher sleep quality and efficiency after active vs. sham stimulation (72).

Negative Study Findings Further Question Effectiveness of ...

Recent research reveals that transcranial direct current stimulation (tDCS) shows no significant benefits for insomnia, highlighting the need for larger ...

Personalized transcranial alternating current stimulation ...

Personalized tACS stimulation increased sleep quantity (duration) by 22 minutes compared to a Control condition (p=.04), and 19 minutes compared to Fixed tACS ...

Effectiveness of non-invasive brain stimulation in improving ...

Despite the promising nature of these techniques, the evidence regarding their effectiveness in improving sleep quality remains inconsistent.

Personalized transcranial alternating current stimulation ...

Electrical brain stimulation has an appealing safety profile, with no harmful adverse side effects tDCS is safe to use in human subjects for repeated use. ...

Wearable Transcranial Electrical Stimulation (tES) for Insomnia

Note: Pregnancy Safety data for tES use in pregnant women is scarce but is reviewed in: Antal, Andrea, et al. "Low intensity transcranial ...

The Effects of Transcranial Electrical Stimulation ...

Results concerning changes in sleep patterns are conflicting, whereas subjective assessments show clear improvements after tES.

Transcranial Electrical Stimulation (TES) at Slow ...

Also called a data safety and monitoring board, or DSMB. sleep from 2100 until 0700 during a seven night period experience a 46 hour period of sleep ...