Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

Early Phase 1

Completed

• Conditions: Sleep; Sleep Hygiene

• Registration Number: NCT04461769
• Lead Sponsor: Brain Electrophysiology Laboratory Company

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-05-30
• Study Completion: 2020-05-30
• Study First Submitted: 2020-06-30
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-02
• Last Update Submitted: 2020-07-02
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
N3 Duration	Measured during the night of sleep (typically 8 hours)	Duration in minutes of N3 sleep

Secondary Outcome Measures

Name	Time	Method
N3 Percentage	Measured during the night of sleep (typically 8 hours)	Percentage of the night's sleep spent in N3

Trial Locations

Locations (1)

Brain Electrophysiology Laboratory Company; 🇺🇸 Eugene, Oregon, United States