Wearable tES for Insomnia
Recruiting in Palo Alto (17 mi)
JK
Overseen byJohn K Werner, MD PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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.12345
Is transcranial direct current stimulation (tDCS) safe for humans?
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.123410
Research Team
JK
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.
See 2 more
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.
See 16 more
Trial 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 (Behavioural Intervention)
- Sham (Behavioural Intervention)
Trial OverviewThe 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
2Treatment groups
Active Control
Placebo Group
Group I: StimulationActive Control1 Intervention
Short duration repetitive (SDR-) tES with a frequency of 0.75Hz
Group II: Sham ConditionPlacebo Group1 Intervention
Sham condition using a low current amplitude at 25 Hz.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Walter Reed National Military Medical CenterBethesda, MD
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Who Is Running the Clinical Trial?
Uniformed Services University of the Health Sciences
Lead Sponsor
Trials
130
Patients Recruited
91,100+
References
Transcranial magnetic stimulation combined with transcranial direct current stimulation in patients with chronic insomnia: a case report. [2023]Long-term insomnia affects the normal life and work of individuals and increases the risk of various health problems, including mental illness. Therefore, there is an urgent need for an efficient and safe treatment for improving sleep. In this study, we report the case a 52-year-old woman who received repetitive transcranial magnetic stimulation (rTMS) combined with transcranial direct current stimulation (tDCS) after agreeing to publish her case. In order to evaluate the quality of sleep and the stability of emotional symptoms, clinical evaluations were conducted at baseline, after 10 treatment sessions, after 20 treatment sessions, and 1 month after the end of treatment. After completing rTMS combined with tDCS, the patient showed an overall clinical improvement, with clinical changes mainly observed in the Pittsburgh Sleep Quality Index, Hamilton Depression Scale, Hamilton Anxiety Scale scores and polysomnography, and this improvement was maintained 1 month after the intervention. This case provides the first evidence for the feasibility, tolerability, and safety of combined rTMS and tDCS in a patient with chronic insomnia.
Transcranial Alternating Current Stimulation (tACS) as a Treatment for Insomnia. [2023]We investigated the effects of transcranial alternating stimulation (tACS) in patients with insomnia. Nine patients with chronic insomnia underwent two in-laboratory polysomnography, 2 weeks apart, and were randomized to receive tACS either during the first or second study. The stimulation was applied simultaneously and bilaterally at F3/M1 and F4/M2 electrodes (0.75 mA, 0.75 Hz, 5-minute). Sleep onset latency and wake after sleep onset dropped on the stimulation night but they did not reach statistical significance; however, there were significant improvements in spontaneous and total arousals, sleep quality, quality of life, recall memory, sleep duration, sleep efficiency, and daytime sleepiness.
Personalized transcranial alternating current stimulation improves sleep quality: Initial findings. [2023]Insufficient sleep is a major health issue. Inadequate sleep is associated with an array of poor health outcomes, including cardiovascular disease, diabetes, obesity, certain forms of cancer, Alzheimer's disease, depression, anxiety, and suicidality. Given concerns with typical sedative hypnotic drugs for treating sleep difficulties, there is a compelling need for alternative interventions. Here, we report results of a non-invasive electrical brain stimulation approach to optimizing sleep involving transcranial alternating current stimulation (tACS). A total of 25 participants (mean age: 46.3, S.D. ± 12.4, 15 females) were recruited for a null-stimulation controlled (Control condition), within subjects, randomized crossed design, that included two variants of an active condition involving 15 min pre-sleep tACS stimulation. To evaluate the impact on sleep quality, the two active tACS stimulation conditions were designed to modulate sleep-dependent neural activity in the theta/alpha frequency bands, with both stimulation types applied to all subjects in separate sessions. The first tACS condition used a fixed stimulation pattern across all participants, a pattern composed of stimulation at 5 and 10 Hz. The second tACS condition used a personalized stimulation approach with the stimulation frequencies determined by each individual's peak EEG frequencies in the 4-6 Hz and 9-11 Hz bands. Personalized tACS stimulation increased sleep quantity (duration) by 22 min compared to a Control condition (p = 0.04), and 19 min compared to Fixed tACS stimulation (p = 0.03). Fixed stimulation did not significantly increase sleep duration compared to Control (mean: 3 min; p = 0.75). For sleep onset, the Personalized tACS stimulation resulted in reducing the onset by 28% compared to the Fixed tACS stimulation (6 min faster, p = 0.02). For a Poor Sleep sub-group (n = 13) categorized with Clinical Insomnia and a high insomnia severity, Personalized tACS stimulation improved sleep duration by 33 min compared to Fixed stimulation (p = 0.02), and 30 min compared to Control condition (p < 0.1). Together, these results suggest that Personalized stimulation improves sleep quantity and time taken to fall asleep relative to Control and Fixed stimulation providing motivation for larger-scale trials for Personalized tACS as a sleep therapeutic, including for those with insomnia.
Slow oscillating transcranial direct current stimulation during sleep has a sleep-stabilizing effect in chronic insomnia: a pilot study. [2018]Recent evidence suggests that lack of slow-wave activity may play a fundamental role in the pathogenesis of insomnia. Pharmacological approaches and brain stimulation techniques have recently offered solutions for increasing slow-wave activity during sleep. We used slow (0.75 Hz) oscillatory transcranial direct current stimulation during stage 2 of non-rapid eye movement sleeping insomnia patients for resonating their brain waves to the frequency of sleep slow-wave. Six patients diagnosed with either sleep maintenance or non-restorative sleep insomnia entered the study. After 1 night of adaptation and 1 night of baseline polysomnography, patients randomly received sham or real stimulation on the third and fourth night of the experiment. Our preliminary results show that after termination of stimulations (sham or real), slow oscillatory transcranial direct current stimulation increased the duration of stage 3 of non-rapid eye movement sleep by 33 ± 26 min (P = 0.026), and decreased stage 1 of non-rapid eye movement sleep duration by 22 ± 17.7 min (P = 0.028), compared with sham. Slow oscillatory transcranial direct current stimulation decreased stage 1 of non-rapid eye movement sleep and wake time after sleep-onset durations, together, by 55.4 ± 51 min (P = 0.045). Slow oscillatory transcranial direct current stimulation also increased sleep efficiency by 9 ± 7% (P = 0.026), and probability of transition from stage 2 to stage 3 of non-rapid eye movement sleep by 20 ± 17.8% (P = 0.04). Meanwhile, slow oscillatory transcranial direct current stimulation decreased transitions from stage 2 of non-rapid eye movement sleep to wake by 12 ± 6.7% (P = 0.007). Our preliminary results suggest a sleep-stabilizing role for the intervention, which may mimic the effect of sleep slow-wave-enhancing drugs.
The Efficacy of Transcranial Current Stimulation Techniques to Modulate Resting-State EEG, to Affect Vigilance and to Promote Sleepiness. [2020]Transcranial Current Stimulations (tCSs) are non-invasive brain stimulation techniques which modulate cortical excitability and spontaneous brain activity by the application of weak electric currents through the scalp, in a safe, economic, and well-tolerated manner. The direction of the cortical effects mainly depend on the polarity and the waveform of the applied current. The aim of the present work is to provide a broad overview of recent studies in which tCS has been applied to modulate sleepiness, sleep, and vigilance, evaluating the efficacy of different stimulation techniques and protocols. In recent years, there has been renewed interest in these stimulations and their ability to affect arousal and sleep dynamics. Furthermore, we critically review works that, by means of stimulating sleep/vigilance patterns, in the sense of enhancing or disrupting them, intended to ameliorate several clinical conditions. The examined literature shows the efficacy of tCSs in modulating sleep and arousal pattern, likely acting on the top-down pathway of sleep regulation. Finally, we discuss the potential application in clinical settings of this neuromodulatory technique as a therapeutic tool for pathological conditions characterized by alterations in sleep and arousal domains and for sleep disorders per se.
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.
Physics of Transcranial Direct Current Stimulation Devices and Their History. [2022]Transcranial direct current stimulation (tDCS) devices apply direct current through electrodes on the scalp with the intention to modulate brain function for experimental or clinical purposes. All tDCS devices include a current controlled stimulator, electrodes that include a disposable electrolyte, and headgear to position the electrodes on the scalp. Transcranial direct current stimulation dose can be defined by the size and position of electrodes and the duration and intensity of current applied across electrodes. Electrode design and preparation are important for reproducibility and tolerability. High-definition tDCS uses smaller electrodes that can be arranged in arrays to optimize brain current flow. When intended to be used at home, tDCS devices require specific device design considerations. Computational models of current flow have been validated and support optimization and hypothesis testing. Consensus on the safety and tolerability of tDCS is protocol specific, but medical-grade tDCS devices minimize risk.
Non-invasive cortical stimulation: Transcranial direct current stimulation (tDCS). [2022]Transcranial direct current stimulation (tDCS) is a re-emerging non-invasive brain stimulation technique that has been used in animal models and human trials aimed to elucidate neurophysiology and behavior interactions. It delivers subthreshold electrical currents to neuronal populations that shift resting membrane potential either toward depolarization or hyperpolarization, depending on stimulation parameters and neuronal orientation in relation to the induced electric field (EF). Although the resulting cerebral EFs are not strong enough to induce action potentials, spontaneous neuronal firing in response to inputs from other brain areas is influenced by tDCS. Additionally, tDCS induces plastic synaptic changes resembling long-term potentiation (LTP) or long-term depression (LTD) that outlast the period of stimulation. Such properties place tDCS as an appealing intervention for the treatment of diverse neuropsychiatric disorders. Although findings of clinical trials are preliminary for most studied conditions, there is already convincing evidence regarding its efficacy for unipolar depression. The main advantages of tDCS are the absence of serious or intolerable side effects and the portability of the devices, which might lead in the future to home-use applications and improved patient care. This chapter provides an up-to-date overview of a number tDCS relevant topics such as mechanisms of action, contemporary applications and safety. Furthermore, we propose ways to further develop tDCS research.
[The effect of transcranial direct current stimulation on dysfunction of bilateral posterior cingulate cortex after sleep deprivation: a preliminary study]. [2020]Objective: To investigate the effects of transcranial direct current stimulation (tDCS) on the disturbance of brain network dysfunction after sleep deprivation (SD). Methods: The experimental design of self-control was used in the study. All 16 subjects received 2 times of 24 h SD with an interval of 3 weeks. After the first normal sleep, 24 h SD and transcranial electrical stimulation (true or false stimulation) intervention (the current magnitude of true and false stimulation was 1 mA, and the action time was 20 min and 2 s, respectively. The intervention experiment lasted for 20 min. ) and the resting magnetic resonance imaging data were collected after the second transcranial electrical stimulation (sham or true stimulation). The resting fMRI data were collected as baseline before SD, the bilateral posterior cingulate cortex in the default mode network was selected as the seed point, and the functional connectivity between the seed points and the whole brain was calculated. Results: Compared with the rest wakefulness, the functional connectivity among bilateral posterior cingulate cortex, bilateral thalamus and hippocampus was increased (P＜0. 01), but connected with the right precuneus, bilateral insula was decreased after 24 h SD (P＜0. 01). Compared with the sham tDCS group, the functional connectivity between left posterior cingulate cortex seed point and right precuneus of tDCS group was increased (P＜0. 01); but decreased with the bilateral thalamus, insula and right cerebral cortex (P＜0. 01). There was a decrease in the functional connectivity among the right posterior cingulate cortex and the bilateral thalamus, right insula, and cerebral cortex(P＜0. 01). Conclusion: 24-hours sleep deprivation can cause functional connection disorder of bilateral posterior cingulate gyrus, and transcranial electrical stimulation can improve the functional connection disorder after sleep deprivation to some extent.
The Effects of Anodal Transcranial Direct Current Stimulation on Sleep Time and Efficiency. [2020]A single session of anodal transcranial direct current stimulation (tDCS) has been shown to increase arousal in healthy participants for up to 24 h post-stimulation. However, little is known about the effects of tDCS on subsequent sleep in this population. Based on previous clinical studies, we hypothesized that anodal stimulation to the left dorsolateral prefrontal cortex (lDLPFC) would produce higher arousal with decreased sleep time and stimulation to the primary motor cortex (M1) would have the converse effect. Thirty-six active duty military were randomized into one of three groups (n = 12/group); active anodal tDCS over the lDLPFC, active anodal tDCS over left M1, or sham tDCS. Participants answered questionnaires 3 times a day and wore a wrist activity monitor (WAM) to measure sleep time and efficiency for 3 weeks. On weeks 2 and 3 (order counterbalance), participants received stimulation at 1800 h before 26 h of sustained wakefulness testing (sleep deprived) and at 1800 h without sleep deprivation (non-sleep deprived). There were no significant effects for the non-sleep deprived portion of testing. For the sleep deprived portion of testing, there were main effects of group and night on sleep time. The DLPFC group slept less than the other groups on the second and third night following stimulation. There is no negative effect on mood or sleep quality from a single dose of tDCS when participants have normal sleep patterns (i.e., non-sleep deprived portion of testing). The results suggest that stimulation may result in faster recovery from fatigue caused by acute periods of sleep deprivation, as their recovery sleep periods were less.