Closed Loop TES for Enhancing Slow Wave Sleep

NCT ID: NCT03751982

Last Updated: 2018-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-14

Study Completion Date

2022-01-14

Brief Summary

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

Detailed Description

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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.

Conditions

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Sleep Disturbance Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

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

Study Groups

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Open-Loop

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.

Group Type ACTIVE_COMPARATOR

Transcranial Electrical Neuromodulation (TES)

Intervention Type DEVICE

TES phase-aligned with slow waves or not

Closed-Loop

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.

Group Type EXPERIMENTAL

Transcranial Electrical Neuromodulation (TES)

Intervention Type DEVICE

TES phase-aligned with slow waves or not

Interventions

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Transcranial Electrical Neuromodulation (TES)

TES phase-aligned with slow waves or not

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* healthy adults

Exclusion Criteria

* persons with epilepsy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brain Electrophysiology Laboratory Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Don M. Tucker

CEO, Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brain Electrophysiology Laboratory Company

Eugene, Oregon, United States

Site Status

Countries

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United States

Central Contacts

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Don M Tucker, PhD

Role: CONTACT

541-653-8266

Phan Luu, PhD

Role: CONTACT

541-653-8266

Facility Contacts

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Don M Tucker, PhD

Role: primary

Other Identifiers

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1R44MH115955

Identifier Type: NIH

Identifier Source: org_study_id

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