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Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
Sponsor: Casa Colina Hospital and Centers for Healthcare
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
Official title: The Impact of Vagus Nerve Stimulation on Improving Sleep for Individuals in an Inpatient Rehab Facility for Post-Acute Ischemic Stroke
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2026-10-16
Completion Date
2027-12-16
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
transauricular Vagal Nerve Stimulation
All participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London). Participants will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Stimulation parameters will be set at 200µs pulse width (with proprietary waveform) and 20Hz. The intensity will be set to level 21 and increased up to 32 as tolerated, but reduced sequentially to intensity level 12 if unable to tolerate due to discomfort. They will include amplitudes 1.0-1.7mA for therapeutic thresholds.
Sham Comparator
All participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London). Participants will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Stimulation parameters will be set to the same parameters as for the experimental group, however his device will include a sham earpiece that will prevent the transmission of taVNS.
Locations (1)
Casa Colina Hospital and Centers for Healthcare
Pomona, California, United States