Wearable tES for Insomnia

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The purpose of this research study is to investigate a new, targeted intervention to improve outcomes for those suffering from insomnia by attempting to enhance the brain rhythms within the frontal lobe implicated in slow wave generation during the transition from wake to sleep. The device applies a pulsed trapezoidal direct current waveform at 0.75 Hz to the frontal areas of the brain immediately prior to attempted sleep onset to facilitate the transition to sleep. During this cross-over trial, patients will be asked to use a PeakSleep wearable neurotechnology prototype headband, which delivers <14 minutes of frontal tDCS over a 30-minute period, immediately before trying to fall asleep. Using an active stimulation versus sham paradigm, we will compare actigraphy data, physiological data, and subjective sleep measures against a pre-treatment baseline in the same patient. Participants will complete five in-person visits over the course of the 8-week study. The first visit includes the collection of baseline self-reported data and actigraphy device training. All subsequent visits involve headset training, downloading PeakSleep and actigraphy data, repeating self-reported data measures, and reporting user experience with the device. Participants will not perform any formal sleep study visits and instead provide daily actigraphy data via a FitBit and EEG data when wearing PeakSleep in their own home. ;

Study Design

Related Conditions & MeSH terms

Insomnia
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT06100185
Study type	Interventional
Source	Uniformed Services University of the Health Sciences
Contact	Adriana Penafiel, BA
Phone	(240) 630-1951
Email	adriana.penafiel.ctr@usuhs.edu
Status	Recruiting
Phase	N/A
Start date	October 25, 2023
Completion date	September 2025

View Details

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