Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep (ESSOTEDS)

Brain Electrophysiology Laboratory Company

Status and phase: Completed; Early Phase 1

Conditions: Sleep; Sleep Hygiene

Treatments: Device: Transcranial Electrical Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT04461769

R44MH115955

Details and patient eligibility

About

This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.

Full description

Previous studies have demonstrated successful synchronization of SOs with slow TES pulses. However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3, F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from frontal neocortex. In the present study, we hypothesized that transcranial electrical stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3 sleep. Furthermore, based on our computational modeling with this more optimal targeting of the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1 or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.

Enrollment: 13 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

• history of seizures
• epilepsy
• brain trauma or injury
• insomnia
• sleep apnea
• medications that may affect the EEG.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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13 participants in 2 patient groups

Slow Oscillation Synchronization with TES

Experimental group

Description:

Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.

Treatment:

Device: Transcranial Electrical Stimulation

Sham Control

Sham Comparator group

Description:

No current delivered.

Treatment:

Device: Transcranial Electrical Stimulation