NCT03751982

Closed Loop TES for Enhancing Slow Wave Sleep

Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Brain Electrophysiology Laboratory Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.

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.

Conditions

• Sleep Disturbance
• Insomnia

Interventions

Type	Name	Description
DEVICE	Transcranial Electrical Neuromodulation (TES)	TES phase-aligned with slow waves or not

Timeline

• Start date: 2020-01-14
• Primary completion: 2021-01-14
• Completion: 2022-01-14
• First posted: 2018-11-23
• Last updated: 2018-11-23

Locations

1 site across 1 country: United States