Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06100185
NA

Wearable Transcranial Electrical Stimulation (tES) for Insomnia

Sponsor: Uniformed Services University of the Health Sciences

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the ability of a translational device, Teledyne PeakSleep, to reduce sleep onset latency, reduce time awake after sleep onset and improve restfulness and the subjective benefits of sleep in a patient population with insomnia via transcranial direct current stimulation (tDCS) applied to frontal lobe circuits.

Official title: Wearable Neurotechnology for Treatment of Insomnia (tES)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-10-25

Completion Date

2026-01

Last Updated

2025-11-10

Healthy Volunteers

No

Conditions

Interventions

DEVICE

PeakSleep

The PeakSleepTM is a constant current device which delivers stable stimulation as a function of the impedance measured across the electrodes (e.g. it varies voltage to produce a steady current). The device gradually ramps up the current as the impedance decreases during the stimulation session. The device uses stimulation amplitudes in the range of 100uA to 500uA at each electrode pair. Devices will be configured to deliver 100 stimulation trains over 30 minutes where each train is 6 pulses of 0.75Hz trapezoidal stimulation (each train lasts 8 seconds). The inter-train interval is 10 seconds leading to a total stimulation time of \<14 minutes with a maximum dose of 1mA (500uA per electrode pair).

DEVICE

Sham

Sham is delivered with the same devices which are alternatively configured to deliver a trivially low amplitude (e.g. 100uA) waveform of a different frequency (e.g. 25 Hz) for the same treatment duration. Beyond differences in amplitude and frequency of stimulation, devices will be operated in exactly the same way during sham treatment.

Locations (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States