Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

NCT ID: NCT04461769

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-05-30

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.

Conditions

Sleep; Sleep Hygiene

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Slow Oscillation Synchronization with TES

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

Group Type: EXPERIMENTAL

Transcranial Electrical Stimulation

Intervention Type: DEVICE

Oscillating electrical current

Sham Control

No current delivered.

Group Type: SHAM_COMPARATOR

Transcranial Electrical Stimulation

Intervention Type: DEVICE

Oscillating electrical current

Interventions

Transcranial Electrical Stimulation

Oscillating electrical current

Intervention Type: DEVICE

Other Intervention Names

Sleep WISP (Wireless Interface Sensor Pod)

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brain Electrophysiology Laboratory Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brain Electrophysiology Laboratory Company

Eugene, Oregon, United States

Countries

United States

Other Identifiers

R44MH115955

Identifier Type: NIH

Identifier Source: org_study_id

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