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Closed Loop TES for Enhancing Slow Wave Sleep

Primary Purpose

Sleep Disturbance, Insomnia

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transcranial Electrical Neuromodulation (TES)

About this trial

This is an interventional basic science trial for Sleep Disturbance focused on measuring transcranial electrical stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

healthy adults

Exclusion Criteria:

persons with epilepsy

Sites / Locations

Brain Electrophysiology Laboratory Company

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Open-Loop

Closed-Loop

Arm Description

In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is not synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.

In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.

Outcomes

Primary Outcome Measures

Slow wave amplitude

Amplitude of slow waves of sleep

Slow wave duration

Duration of slow wave period in sleep

Secondary Outcome Measures

Full Information

NCT ID

NCT03751982

First Posted

November 8, 2018

Last Updated

November 21, 2018

Sponsor

Brain Electrophysiology Laboratory Company

1. Study Identification

Unique Protocol Identification Number

NCT03751982

Brief Title

Closed Loop TES for Enhancing Slow Wave Sleep

Official Title

Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 14, 2020 (Anticipated)

Primary Completion Date

January 14, 2021 (Anticipated)

Study Completion Date

January 14, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brain Electrophysiology Laboratory Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.

Detailed Description

Note: FDA has determined that TES with the stimulus parameters as specified for this trial presents no significant risk, so that FDA clearance is not required. Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly effective if it is aligned with ongoing brain activity. One condition of the present research is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during slow wave sleep. The other condition is a closed-loop design, using identical pulses, but these will be phase aligned with the slow waves of sleep, measured by the electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in enhancing the amplitude and duration of slow wave sleep than open-loop TES.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disturbance, Insomnia

Keywords

transcranial electrical stimulation

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Within subjects comparison of two effective treatments. Order of treatment is randomized and counterbalanced.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The phase alignment of the treatment is set in software and not revealed to participant or experimenter. Order of treatment is randomized and counterbalanced.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Open-Loop

Arm Type

Active Comparator

Arm Description

Arm Title

Closed-Loop

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Transcranial Electrical Neuromodulation (TES)

Intervention Description

TES phase-aligned with slow waves or not

Primary Outcome Measure Information:

Title

Slow wave amplitude

Description

Amplitude of slow waves of sleep

Time Frame

Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.

Title

Slow wave duration

Description

Duration of slow wave period in sleep

Time Frame

Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: healthy adults Exclusion Criteria: persons with epilepsy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Don M Tucker, PhD

Phone

541-653-8266

don.tucker@belco.tech

First Name & Middle Initial & Last Name or Official Title & Degree

Phan Luu, PhD

Phone

541-653-8266

phan.luu@belco.tech

Facility Information:

Facility Name

Brain Electrophysiology Laboratory Company

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97405

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Don M Tucker, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Closed Loop TES for Enhancing Slow Wave Sleep

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