Closed Loop TES for Enhancing Slow Wave Sleep

NCT03751982 | Unknown

• 1 other identifier: 1R44MH115955
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Disturbance; Insomnia

Keywords

transcranial electrical stimulation

Outcome Measures

Primary Outcomes (2)

• Slow wave amplitude

  Amplitude of slow waves of sleep

  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.

• Slow wave duration

  Duration of slow wave period in sleep

  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.

Study Arms (2)

Open-Loop

ACTIVE COMPARATOR

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.

Device: Transcranial Electrical Neuromodulation (TES)

Closed-Loop

EXPERIMENTAL

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.

Device: Transcranial Electrical Neuromodulation (TES)

Interventions

Transcranial Electrical Neuromodulation (TES) DEVICE

TES phase-aligned with slow waves or not

Closed-Loop; Open-Loop

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adults

You may not qualify if:

• persons with epilepsy

Sponsors & Collaborators

• Brain Electrophysiology Laboratory Company: lead

Study Sites (1)

Brain Electrophysiology Laboratory Company

Eugene, Oregon, 97405, United States

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

Don M Tucker, PhD

CONTACT

541-653-8266; don.tucker@belco.tech

Phan Luu, PhD

CONTACT

541-653-8266; phan.luu@belco.tech

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The phase alignment of the treatment is set in software and not revealed to participant or experimenter. Order of treatment is randomized and counterbalanced.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO, Senior Scientist

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

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 23, 2018
• Study Start: January 14, 2020
• Primary Completion: January 14, 2021
• Study Completion: January 14, 2022
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)