NCT07858656 Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
| NCT ID | NCT07858656 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Casa Colina Hospital and Centers for Healthcare |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2026-10-16 |
| Primary Completion | 2027-10-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 52 participants in total. It began in 2026-10-16 with a primary completion date of 2027-10-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Emily Rosario, PhD
STUDY DIRECTOR
Casa Colina Hospital and Centers for Healthcare
Frequently Asked Questions
Who can join the NCT07858656 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07858656 currently recruiting?
Yes, NCT07858656 is actively recruiting participants. Contact the research team at myeseta@casacolina.org for enrollment information.
Where is the NCT07858656 trial being conducted?
This trial is being conducted at Pomona, United States.
Who is sponsoring the NCT07858656 clinical trial?
NCT07858656 is sponsored by Casa Colina Hospital and Centers for Healthcare. The principal investigator is Emily Rosario, PhD at Casa Colina Hospital and Centers for Healthcare. The trial plans to enroll 52 participants.
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