Closed Loop TES for Enhancing Slow Wave Sleep

Insomnia Clinical Trial

Official title:

Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03751982
• Other study ID #: 1R44MH115955
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: January 14, 2022

Study information

• Verified date: November 2018
• Source: Brain Electrophysiology Laboratory Company
• Contact: Don M Tucker, PhD
• Phone: 541-653-8266
• Email: don.tucker[@]belco.tech
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 14, 2022
• Est. primary completion date: January 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy adults

Exclusion Criteria:

• persons with epilepsy

Related Conditions & MeSH terms

• Dyssomnias
• Insomnia
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Device:
• Transcranial Electrical Neuromodulation (TES)
TES phase-aligned with slow waves or not

Locations

Country	Name	City	State
United States	Brain Electrophysiology Laboratory Company	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Brain Electrophysiology Laboratory Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.