Closed Loop TES for Enhancing Slow Wave Sleep

Study Overview
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Brief Summary
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Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.

Detailed Description
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Note: FDA has determined that TES with the stimulus parameters as specified for this trial presents no significant risk, so that FDA clearance is not required. Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly effective if it is aligned with ongoing brain activity. One condition of the present research is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during slow wave sleep. The other condition is a closed-loop design, using identical pulses, but these will be phase aligned with the slow waves of sleep, measured by the electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in enhancing the amplitude and duration of slow wave sleep than open-loop TES.

Official Title
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Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation

Conditions
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Sleep Disturbance, Insomnia

Intervention / Treatment
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* Device: Transcranial Electrical Neuromodulation (TES)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy adults Exclusion Criteria: persons with epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Within subjects comparison of two effective treatments. Order of treatment is randomized and counterbalanced.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open-Loop<br>In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is not synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz. | Device: Transcranial Electrical Neuromodulation (TES)<br>* TES phase-aligned with slow waves or not<br>|
| Experimental: Closed-Loop<br>In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz. | Device: Transcranial Electrical Neuromodulation (TES)<br>* TES phase-aligned with slow waves or not<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slow wave amplitude | Amplitude of slow waves of sleep | Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night. | 
| Slow wave duration | Duration of slow wave period in sleep | Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial electrical stimulation