No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
52 (estimated)
Sponsor
Casa Colina Hospital and Centers for Healthcare · Other
Who this trial is looking for
This trial is looking for people recovering from a stroke who have sleep problems. Participants will use a device on their ear for 30 minutes every evening over at least 10 nights while in rehabilitation.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have been diagnosed with ischemic stroke
I have sleep problems as confirmed by the Insomnia Severity Index
I speak English or Spanish
I can understand and follow instructions
I am being treated at Casa Colina's acute rehabilitation service
You may not be able to join if
I have had a hemorrhagic stroke
I have other confirmed neurological diagnoses
I have previously had surgery on my vagus nerve
I have open wounds or cancerous lesions near my ear
I have severe bradycardia
I have a permanent implanted device or jewelry near my ear
I had trigeminal neuralgia in the past year
I am pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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'…
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
Trial Locations
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Facility
City
State
Country
Status
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…
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
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