Casa Colina Hospital and Centers for Healthcare
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
For this randomized control trial, all patients admitted to Casa Colina's acute rehabilitation unit with a diagnosis of stroke will be screened against inclusion and exclusion criteria. Participants will be assessed using a cognition screen via the Mini Mental Exam and the Insomnia Severity Index (ISI), a validated tool for measuring and grading the presence of insomnia. The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will be randomized into the intervention group or sham treatment group. All participants will re…
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 o…
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.
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.
Arctuva estimate
Verify or correct the compensation shown for this listing.