Closed Loop TES for Enhancing Slow Wave Sleep

Brain Electrophysiology Laboratory Company

Status: Unknown

Conditions: Insomnia; Sleep Disturbance

Treatments: Device: Transcranial Electrical Neuromodulation (TES)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03751982

1R44MH115955

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy adults

Exclusion criteria

• persons with epilepsy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Open-Loop

Active Comparator group

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.

Treatment:

Device: Transcranial Electrical Neuromodulation (TES)

Closed-Loop

Experimental group

Description:

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.

Treatment:

Device: Transcranial Electrical Neuromodulation (TES)