Wearable tES for Insomnia

Overseen By Sonja T Skeete, 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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate the ability of a translational device, Teledyne PeakSleep, to reduce sleep onset latency, reduce time awake after sleep onset and improve restfulness and the subjective benefits of sleep in a patient population with insomnia via transcranial direct current stimulation (tDCS) applied to frontal lobe circuits.

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 data supports the effectiveness of the treatment PeakSleep for insomnia?

Research shows that transcranial direct current stimulation (tDCS), a component of PeakSleep, can improve sleep quality and efficiency in people with insomnia. Studies have found that tDCS can increase sleep duration and reduce the time it takes to fall asleep, suggesting it may be a promising treatment for sleep issues. ^{1 2 3 4 5}

Is transcranial direct current stimulation (tDCS) safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with most studies reporting only mild and temporary side effects. Medical-grade tDCS devices are designed to minimize risks, and there is no evidence of serious or intolerable side effects. ^{1 6 7 8 9}

How is the treatment PeakSleep different from other treatments for insomnia?

PeakSleep, a type of transcranial direct current stimulation (tDCS), is unique because it uses a non-invasive electrical brain stimulation method to improve sleep quality by modulating brain activity. Unlike traditional sedative drugs, it offers a personalized approach by adjusting the stimulation frequencies based on individual brain patterns, potentially leading to better sleep duration and faster sleep onset. ^{1 2 3 4 10}

Research Team

John K Werner, MD PhD

Principal Investigator

Uniformed Services University of the Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Stimulation Active Control 1 Intervention

Short duration repetitive (SDR-) tES with a frequency of 0.75Hz

Group II: Sham Condition Placebo Group 1 Intervention

Sham condition using a low current amplitude at 25 Hz.

Who Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials

130

Recruited

91,100+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation combined with transcranial direct current stimulation in patients with chronic insomnia: a case report. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Transcranial Alternating Current Stimulation (tACS) as a Treatment for Insomnia. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Personalized transcranial alternating current stimulation improves sleep quality: Initial findings. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Slow oscillating transcranial direct current stimulation during sleep has a sleep-stabilizing effect in chronic insomnia: a pilot study. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of Transcranial Current Stimulation Techniques to Modulate Resting-State EEG, to Affect Vigilance and to Promote Sleepiness. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Physics of Transcranial Direct Current Stimulation Devices and Their History. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Non-invasive cortical stimulation: Transcranial direct current stimulation (tDCS). [2022]

9. China 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]. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Anodal Transcranial Direct Current Stimulation on Sleep Time and Efficiency. [2020]