Ear-based nerve stimulation to help sleep after a stroke
Official title: The Impact of Vagus Nerve Stimulation on Improving Sleep for Individuals in an Inpatient Rehab Facility for Post-Acute Ischemic Stroke
Run by Casa Colina Hospital and Centers for Healthcare · NCT07858656 · Data updated 2026-11-12
A device that delivers vagal nerve stimulation through the ear is tested to see if it helps stroke patients in rehab sleep better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Casa Colina Hospital and Centers for Healthcare Academic / other |
| Locations | 1 site (Pomona, California) |
| Status | Recruiting |
| Started | October 16, 2026 |
| Main results expected | October 16, 2027 |
| Study ends | December 16, 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07858656 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 or older with ischemic stroke admitted to Casa Colina's acute rehabilitation unit, who speak English or Spanish and have enough cognition to follow instructions.
✕Probably not a fit
Patients with intracerebral hemorrhage, other neurological diagnoses, ear wounds near the tragus, or contraindications to taVNS may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, sham-controlled trial tests whether transauricular vagal nerve stimulation (taVNS) can improve sleep in adults recovering from ischemic stroke who are in an inpatient rehabilitation unit. Participants use a non-invasive ear clip device for 30 minutes each evening for at least 10 nights, with randomization to either active stimulation or a sham device. Sleep and cognitive status are evaluated with validated tools, including the Insomnia Severity Index and a cognitive screen, to assess any impact on sleep, stroke-related symptoms, and daily functioning. The study follows a standardized stimulation protocol and tracks side effects and bedtime routines to understand tolerability and potential benefits.
Why it matters
Potential benefit: If successful, the device could offer a non-drug option to improve sleep and potentially support recovery after stroke.
How similar studies have gone: Previous studies in post-stroke symptoms have explored taVNS, with varying results but some evidence supporting potential benefits on neurological symptoms and sleep.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Admitted to Casa Colina's acute rehabilitation service 2. Diagnosis of ischemic stroke 3. Age 18 years or older 4. English or Spanish speaking 5. Sufficient cognition to follow program instructions tested Mini Mental Exam (score \>17/30) 6. Confirmed sleep abnormalities based on the Insomnia Severity Index (ISI) meeting criteria for subthreshold or clinical insomnia (score \>7/28) Exclusion Criteria: 1. Hemorrhagic stroke or hemorrhagic conversion of ischemic stroke 2. Other confirmed neurological diagnoses 3. Previous surgical intervention on the vagus nerve 4. Any open wound or cancerous lesions at the ear within 1 inch of the ear tragus 5. 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
Where it's running
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Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States Recruiting
Study contacts
- Study coordinator: Marie Yeseta, PT, DPT, NCS
- Email: myeseta@casacolina.org
- Phone: 9095967733
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.