Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCasa Colina Hospital and Centers for Healthcare
About this trial
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
This trial does not accept healthy volunteersQualifiers
Admitted to Casa Colina's acute rehabilitation service
Diagnosis of ischemic stroke
Age 18 years or older
English or Spanish speaking
Disqualifiers
Hemorrhagic stroke or hemorrhagic conversion of ischemic stroke
Other confirmed neurological diagnoses
Previous surgical intervention on the vagus nerve
Any open wound or cancerous lesions at the ear within 1 inch of the ear tragus
Trial design
Design model
Parallel
Treatments tested in this trial
transauricular Vagal Nerve Stimulation
DeviceAll 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
DeviceAll 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.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: transauricular Vagal Nerve Stimulation (taVNS)Experimental treatment 1 intervention
Group B: Sham transauricular Vagal Nerve Stimulation (Sham taVNS)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Insomnia Severity Index
A brief screening tool for insomnia including seven items assessing the nature and symptoms of their sleep issues. Questions relate to the responder's sleep, symptom severity and satisfaction with their sleep, as well as the effect of their insomnia on daily function, social impact, and overall distress related to their sleep. Each question is answered on a 5-point Likert scale. Total scores range from 0-28, with a higher score indicating worse insomnia severity.
Time frame
Initial assessment on Day 3-5 of their inpatient stay. Reassessment at 12-15 days, or earlier if the patient discharges prior to this timeline.Secondary outcomes
1
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Admission and Discharge Scores - GG and C sections
Standardized assessments by the healthcare team regarding level of assistance required by the participant for mobility, self-care, and cognition. The GG section assesses self-care (7 items) and mobility (17 items) on a scale from 1-6, with a higher number indicating greater independence. If a participant is unwilling or unsafe to perform an activity, or if the activity is not applicable or there is an environmental limitation, special codes can be applied. The C section of the IRF-PAI assesses cognition via the Brief Interview for Mental Status comprising repetition of 3 words, temporal orientation, and recall. Participants are scored in this section from 1-15 with a higher score indicating better cognition. The presence of any acute-onset mental status change is considered here.
Time frame
Assessed within 48 hours of admission, re-assessed at discharge (with a typical length of stay of 12 to 15 days).Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: