Wearable tES for Insomnia

Overseen By Heather Decot, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Uniformed Services University of the Health Sciences

Must not be taking: Narcotics, Benzodiazepines, SSRI/SNRIs, others

Disqualifiers: Neurological disorders, Unstable psychiatric, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device, PeakSleep, to determine if it can help people with insomnia fall asleep faster and sleep better. The device uses transcranial direct current stimulation (tDCS), which sends gentle electrical signals to the brain to potentially improve sleep. Participants will be divided into two groups: one will use the real device, while the other will use a sham (inactive) version. The trial seeks individuals diagnosed with trouble falling asleep who have not used sleep medications in the past two weeks. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance sleep health for many.

Will I have to stop taking my current medications?

If you are currently taking medication for insomnia, you will need to stop treatment for at least 2 weeks before joining the study. If you are on other medications, especially those related to psychiatric conditions, you should not have had any changes in the last 4 weeks.

What prior data suggests that the Teledyne PeakSleep device is safe for treating insomnia?

Research has shown that the method used by the PeakSleep device, transcranial direct current stimulation (tDCS), is generally safe. Studies indicate that most people tolerate tDCS well. Common side effects are mild and may include a slight tingling sensation or skin irritation where the device contacts the head. Serious side effects are rare.

Because the PeakSleep device uses this technology, it is likely safe for use. However, as with any treatment, individual experiences may vary. Consulting a healthcare professional about any concerns before joining a trial is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PeakSleep for insomnia because it introduces a novel approach by using a wearable transcranial electrical stimulation (tES) device. Unlike traditional treatments like medication or cognitive behavioral therapy, PeakSleep offers a non-invasive, drug-free solution that can be easily used at home. This device aims to gently stimulate brain activity to help regulate sleep patterns, which could provide a more natural and accessible alternative for those struggling with insomnia.

What evidence suggests that the Teledyne PeakSleep device is effective for insomnia?

Research has shown that PeakSleep, a wearable device using a gentle electrical current to stimulate the brain, can significantly aid people with insomnia. One study found that the device reduced the time to fall asleep by 53% compared to before its use. Another study demonstrated that this brain stimulation improved overall sleep quality and efficiency for those with insomnia. Additionally, other research confirms that similar techniques effectively promote sleep and reduce daytime tiredness. These findings suggest that PeakSleep, which participants in this trial may receive, holds strong potential to improve sleep quality for those struggling with insomnia. ^{1 6 7 8 9}

Who Is on the Research Team?

John K Werner, MD PhD

Principal Investigator

Uniformed Services University of the Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with sleep onset insomnia who are Tricare eligible. They can have had non-drug therapy like CBT if it ended over two weeks ago and haven't used sleep meds recently. Excluded are those with hearing aids, metal implants (except dental), tattoos on the head, substance abuse issues, unstable psychiatric disorders, recent major surgery or hospitalization, neurological conditions, or excessive alcohol intake.

Inclusion Criteria

I have been diagnosed with difficulty falling asleep.

I have been diagnosed with insomnia.

I stopped any non-drug therapy, like CBT, more than 14 days ago.

Exclusion Criteria

Non-removable metal anywhere in the body except bridges or fillings

You drink more than 10 alcoholic drinks every week.

You have had thoughts of hurting yourself or thinking about suicide in the past two weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline

Collection of baseline self-reported data and actigraphy device training

2 weeks

1 visit (in-person)

Treatment

Participants use the PeakSleep wearable neurotechnology prototype headband for tDCS treatment

6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PeakSleep
• Sham

Trial Overview

The study tests a device called PeakSleep against a sham (fake) treatment to see if it helps people with insomnia fall asleep faster and feel more rested. It uses tDCS applied to the frontal lobe of the brain to potentially improve sleep quality.

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 1 Intervention

Group II: Sham Arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials

130

Recruited

91,100+

Published Research Related to This Trial

Transcranial direct current stimulation (tDCS) is a non-invasive technique that can influence neuronal activity and induce lasting synaptic changes, making it a promising treatment for neuropsychiatric disorders, particularly unipolar depression.

tDCS is advantageous due to its minimal side effects and potential for portability, which could allow for home use and enhance patient care in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive cortical stimulation: Transcranial direct current stimulation (tDCS). Sudbrack-Oliveira, P., Razza, LB., Brunoni, AR.[2022]

Sleep deprivation for 24 hours disrupts the functional connectivity of the brain, particularly affecting the bilateral posterior cingulate cortex and its connections with other brain regions like the thalamus and hippocampus.

Transcranial direct current stimulation (tDCS) can partially restore these disrupted connections, improving connectivity between the posterior cingulate cortex and the right precuneus, while also reducing connectivity with other areas affected by sleep deprivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of transcranial direct current stimulation on dysfunction of bilateral posterior cingulate cortex after sleep deprivation: a preliminary study]. Meng, QQ., Li, JY., Guo, DL., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized transcranial alternating current stimulation improves sleep quality: Initial findings. Ayanampudi, V., Kumar, V., Krishnan, A., et al.[2023]

Anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (lDLPFC) resulted in reduced sleep time for active duty military personnel during sleep deprivation, indicating it may enhance arousal and recovery from fatigue.

In contrast, there were no significant effects on sleep or mood in participants with normal sleep patterns, suggesting that tDCS does not negatively impact sleep quality when individuals are not sleep deprived.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Anodal Transcranial Direct Current Stimulation on Sleep Time and Efficiency. McIntire, LK., McKinley, RA., Goodyear, C., et al.[2020]

Transcranial direct current stimulation (tDCS) is a non-invasive method that uses controlled electrical currents through electrodes on the scalp to modulate brain function, with device design being crucial for effectiveness and user comfort.

High-definition tDCS, which employs smaller electrodes in specific arrangements, can enhance the precision of brain stimulation, and while safety is generally protocol-specific, using medical-grade devices helps minimize risks associated with tDCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physics of Transcranial Direct Current Stimulation Devices and Their History. Truong, DQ., Bikson, M.[2022]

In a study involving 6 patients with insomnia, slow oscillatory transcranial direct current stimulation significantly increased the duration of deep sleep (stage 3) by an average of 33 minutes and improved overall sleep efficiency by 9%.

The stimulation also reduced the time spent in light sleep (stage 1) and decreased wake time after sleep onset, suggesting that this technique may effectively stabilize sleep patterns and mimic the effects of medications that enhance slow-wave sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow oscillating transcranial direct current stimulation during sleep has a sleep-stabilizing effect in chronic insomnia: a pilot study. Saebipour, MR., Joghataei, MT., Yoonessi, A., et al.[2018]

In a study involving nine patients with chronic insomnia, transcranial alternating stimulation (tACS) showed promising effects on sleep parameters, including improvements in sleep quality, sleep duration, and daytime sleepiness, although not all results reached statistical significance.

The stimulation, applied for 5 minutes at a low current, also led to reductions in spontaneous and total arousals, suggesting that tACS may enhance overall sleep stability and quality in patients with insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Alternating Current Stimulation (tACS) as a Treatment for Insomnia. Motamedi, GK., Jeliazkov, PG., Oyegbile-Chidi, TO., et al.[2023]

A 52-year-old woman with chronic insomnia showed significant improvement in sleep quality and emotional stability after receiving a combination of repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) over 20 treatment sessions.

The improvements were measured using various clinical scales and were maintained one month after treatment, indicating that this combined approach is feasible, tolerable, and safe for treating chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation combined with transcranial direct current stimulation in patients with chronic insomnia: a case report. Zhou, Q., Liu, Z., Zhao, S., et al.[2023]

Transcranial Current Stimulation (tCS) is a safe and well-tolerated non-invasive technique that can effectively modulate sleepiness, sleep, and vigilance by applying weak electric currents to the scalp.

Recent studies indicate that tCS can influence sleep and arousal patterns, suggesting its potential as a therapeutic tool for treating sleep disorders and other clinical conditions related to sleep and arousal regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Transcranial Current Stimulation Techniques to Modulate Resting-State EEG, to Affect Vigilance and to Promote Sleepiness. Annarumma, L., D'Atri, A., Alfonsi, V., et al.[2020]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

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Wearable Neurotechnology for the Treatment of Insomnia

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Wearable tES for Insomnia

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