NCT07858656Not yet recruiting
Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
The Impact of Vagus Nerve Stimulation on Improving Sleep for Individuals in an Inpatient Rehab Facility for Post-Acute Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 52 (estimated)
- First submitted
- 29 Sept 2026
- Start date
- 16 Oct 2026
- Primary completion date
- 16 Oct 2027
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Diseases
- Stroke
- NCT number
- NCT07858656
What you commit to
- Study type: Interventional
- Planned participants: 52
- From 16 Oct 2026 to the primary completion date, 16 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgical intervention on the vagus nerve
Other illness
- 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
- Other confirmed neurological diagnoses
- Any open wound or cancerous lesions at the ear within 1 inch of the ear tragus
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Casa Colina Hospital and Centers for Healthcare Coordinator of this site? Confirm its status | Pomona | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.