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

July 2, 2020 updated by: Brain Electrophysiology Laboratory Company
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97405
        • Brain Electrophysiology Laboratory Company

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: Transcranial Electrical Stimulation
Oscillating electrical current
Other Names:
  • Sleep WISP (Wireless Interface Sensor Pod)
SHAM_COMPARATOR: Sham Control
No current delivered.
Device: Transcranial Electrical Stimulation
Oscillating electrical current
Other Names:
  • Sleep WISP (Wireless Interface Sensor Pod)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N3 Duration
Time Frame: Measured during the night of sleep (typically 8 hours)
Duration in minutes of N3 sleep
Measured during the night of sleep (typically 8 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N3 Percentage
Time Frame: Measured during the night of sleep (typically 8 hours)
Percentage of the night's sleep spent in N3
Measured during the night of sleep (typically 8 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brain Electrophysiology Laboratory Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2019

Primary Completion (ACTUAL)

May 30, 2020

Study Completion (ACTUAL)

May 30, 2020

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

July 2, 2020

First Posted (ACTUAL)

July 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • R44MH115955 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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