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Wearable Transcranial Electrical Stimulation (tES) for Insomnia

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv5 Show 4 more changesShow less
    • Enrollment target: estimated 100 to confirmed 78
    • Primary completion date changed from estimate of Dec 2025 to Jan 29, 2025
    • Study completion date: Jan 2026 to Jun 7, 2026
    • Site details revised
  2. Primary completion date: Sep 2025 to Dec 2025
    • Study completion date: Sep 2025 to Jan 2026
    • Study title expanded, about 3 words
    v4
  3. Enrollment target: 60 to 100
    • Eligibility criteria expanded, about 132 words
    • Secondary endpoints: 7 to 5
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 2023 to Oct 25, 2023
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06100185
Lead Sponsor Uniformed Services University of the Health Sciences
Conditions
(from sponsor)		 Insomnia
Related terms Sleep Initiation and Maintenance Disorders
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov