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Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 42 days later Sep 4, 2027 → Oct 16, 2027
See other at-risk trials from Casa Colina Hospital and Centers for Healthcare

Record History

  1. Start date pushed from Sep 4, 2026 to Oct 16, 2026
    • Primary completion pushed from Sep 4, 2027 to Oct 16, 2027
    • Study completion pushed from Nov 4, 2027 to Dec 16, 2027
    • Secondary endpoints: details revised at 1 of 1 entry
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this clinical trial is to learn if a device which provides vagal nerve stimulation, applied to the tragus of the ear via an ear clip, can improve sleep in individuals recovering from stroke while they are treated in a rehabilitation hospital. The main questions this study aims to answer are: 1. Does using this device improve insomnia? 2. Does this device have any impact on the person's stroke severity, mobility, self-care, or ability to think? Researchers will compare this treatment to a sham (a look-alike device that will not deliver the stimulation). Participants will: * Complete questionnaires about insomnia and their ability to think * Use the device for 30 minutes every evening for at least 10 nights during their inpatient stay * Complete a log tracking their use of the device and any concerns
Trial Details
NCT Number NCT07858656
Lead Sponsor Casa Colina Hospital and Centers for Healthcare
Conditions
(from sponsor)		 Stroke, Ischemic Cerebrovascular Accident, Ischemic Stroke, Vagal Nerve Stimulation
Related terms Ischemic Stroke, Stroke
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov