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StrokeSleepCognitive functionBrain and nervesDevice

What this study is

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

What's being tested

  • transauricular Vagal Nerve Stimulation

    Intervention · DEVICE

    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

    Intervention · DEVICE

    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.

Study details

Official title
The Impact of Vagus Nerve Stimulation on Improving Sleep for Individuals in an Inpatient Rehab Facility for Post-Acute Ischemic Stroke
Sponsor
Casa Colina Hospital and Centers for Healthcare
Conditions
Stroke · Ischemic Cerebrovascular Accident · Ischemic Stroke · Vagal Nerve Stimulation
Enrolling
52 people
Starts
2026-10-16
Est. completion
2027-12-16
Design
Double-blind, randomized, parallel groups
Record
View on ClinicalTrials.gov ↗