Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

Sleep Clinical Trial

— ESSOTEDS  

Official title:

Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461769
• Other study ID #: R44MH115955
• Status: Completed
• Phase: Early Phase 1
• Start date: September 1, 2019
• Est. completion date: May 30, 2020

Study information

• Verified date: July 2020
• Source: Brain Electrophysiology Laboratory Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

-

Exclusion Criteria:

• history of seizures

• epilepsy

• brain trauma or injury

• insomnia

• sleep apnea

• medications that may affect the EEG.

Related Conditions & MeSH terms

• Sleep
• Sleep Hygiene

Intervention

Device:
• Transcranial Electrical Stimulation
Oscillating electrical current

Locations

Country	Name	City	State
United States	Brain Electrophysiology Laboratory Company	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Brain Electrophysiology Laboratory Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	N3 Duration	Duration in minutes of N3 sleep	Measured during the night of sleep (typically 8 hours)
Secondary	N3 Percentage	Percentage of the night's sleep spent in N3	Measured during the night of sleep (typically 8 hours)