Closed Loop TES for Enhancing Slow Wave Sleep
Overview
Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.
Full Title of Study: “Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Basic Science
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: January 14, 2021
Detailed Description
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.
Interventions
- Device: Transcranial Electrical Neuromodulation (TES)
- TES phase-aligned with slow waves or not
Arms, Groups and Cohorts
- Active Comparator: Open-Loop
- 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.
- Experimental: Closed-Loop
- 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.
Clinical Trial Outcome Measures
Primary Measures
- Slow wave amplitude
- Time Frame: 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.
- Amplitude of slow waves of sleep
- Slow wave duration
- Time Frame: 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.
- Duration of slow wave period in sleep
Participating in This Clinical Trial
Inclusion Criteria
- healthy adults Exclusion Criteria:
- persons with epilepsy
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Brain Electrophysiology Laboratory Company
- Provider of Information About this Clinical Study
- Principal Investigator: Don M. Tucker, CEO, Senior Scientist – Brain Electrophysiology Laboratory Company
- Overall Contact(s)
- Don M Tucker, PhD, 541-653-8266, don.tucker@belco.tech
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