Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
Key facts
- Where
- Pomona, United StatesSee the site
Where in United States
- Casa Colina Hospital and Centers for HealthcarePomona, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Casa Colina Hospital and Centers for Healthcare
- Trial code
- NCT07858656
- Record updated
- 4 November 2026
- Original description
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:Read full original descriptionShow less
The Impact of Vagus Nerve Stimulation on Improving Sleep for Individuals in an Inpatient Rehab Facility for Post-Acute Ischemic Stroke
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
Inclusion: Admitted to Casa Colina's acute rehabilitation service; Diagnosis of ischemic stroke; Age 18 years or older; English or Spanish speaking; Sufficient cognition to follow program instructions tested Mini Mental Exam (score >17/30); Confirmed sleep abnormalities based on the Insomnia Severity Index (ISI) meeting criteria for subthreshold or clinical insomnia (score >7/28).
Exclusion: Previous surgical intervention on the vagus nerve; Hemorrhagic stroke or hemorrhagic conversion of ischemic stroke; Contraindication to the device, including patients with severe bradycardia, patients with a permanent implanted metallic or electronic device or jewelry at close proximity (2cm) to the ear tragus, patients with a recent (within 1 year) history of trigeminal neuralgia, pregnancy; Other confirmed neurological diagnoses; Any open wound or cancerous lesions at the ear within 1 inch of the ear tragus.