StrokeNCT07858656
Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
A study testing transauricular Vagal Nerve Stimulation in people with Stroke and Ischemic Cerebrovascular Accident, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic Cerebrovascular Accident, Ischemic Stroke
- What is being tested?
- transauricular Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2026to 16 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Casa Colina's acute rehabilitation service
- Diagnosis of ischemic stroke
- Age 18 years or older
- English or Spanish speaking
- Sufficient cognition to follow program instructions tested Mini Mental Exam (score >17/30)
- Confirmed sleep abnormalities based on the Insomnia Severity Index (ISI) meeting criteria for subthreshold or clinical insomnia (score >7/28)
Who cannot join
- 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
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767
Niko Fullmer, 9095967733 ext. 2220, NFullmer@casacolina.org
Emily Rosario, PhD, 9095967733 ext. 3316, ERosario@casacolina.org
About this study
Official title: The Impact of Vagus Nerve Stimulation on Improving Sleep for Individuals in an Inpatient Rehab Facility for Post-Acute Ischemic Stroke
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:
- Does using this device improve insomnia?
- 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).
Read more
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
Read the detailed description
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 receive a handout on sleep hygiene. All participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. In line with previous studies investigating the impact of taVNS on other post-stroke symptoms, the intervention group 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 previously studied in stroke research (Li 2022) and allow for uniformity of application of the device between treatment and sham groups. The sham treatment group will be instructed in using the Parasym device the same way, however, their issued devices will include a sham earpiece that will prevent the transmission of taVNS. Reassessment of the ISI will be completed at 12-15 days, or earlier if the patient discharges prior to this timeline. A short 2-week taVNS program has been reported to have some effect on insomnia (Liu 2025) in a non-stroke population and this timeline has also been chosen as it coincides with the current typical length of stay for individuals post stroke in the acute rehabilitation unit.
All participants of the study will continue to receive the usual care for their individual rehabilitation program including therapy and medication interventions. Additional data will be collected beyond the screening tests including demographic information, stroke location, time since stroke, history of prior stroke, history of diabetes, NIH stroke scale on admission, record of medications that may impact sleep, consult to neurology service, use of respiratory devices on admission or during their rehab course (supplemental O2, CPAP, BiPAP), and GG and C scores of the IRF-PAI for mobility, self-care, and cognition.
- Being tested
- transauricular Vagal Nerve Stimulation, Sham Comparator
- Keywords
- Vagal Nerve Stimulation, Post Acute Care, Stroke, Cerebrovascular Accident
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transauricular Vagal Nerve StimulationDevice
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 ComparatorDevice
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 group | Role | What they receive |
|---|---|---|
| transauricular Vagal Nerve Stimulation (taVNS) | Experimental | Participants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Reassessment of the ISI will be completed at 12-15 days, or earlier if the patient discharges prior to this timeline. These participants will continue to receive the usual care for their individual rehabilitation program including therapy and medication interventions. Receives: Device: transauricular Vagal Nerve Stimulation |
| Sham transauricular Vagal Nerve Stimulation (Sham taVNS) | Sham comparator | Participants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. For this group, their issued devices will include a sham earpiece that will prevent transmission of taVNS. The ISI will be re-assessed at 12-15 days, or earlier if the patient discharges prior to this timeline. Participants will continue to receive the usual care for their individual rehabilitation program, including therapy and medications. Receives: Device: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessed within 48 hours of admission, re-assessed at discharge (with a typical length of stay of 12 to 15 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start16 Oct 2026
- Primary completion16 Oct 2027 (estimated)
- Study completion16 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa Colina Hospital and Centers for Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Rosario, PhD, Study director, Casa Colina Hospital and Centers for Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858656
- Sponsor's protocol ID
- SleepVNS
- Status last verified
- Nov 2026
- First submitted
- 29 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zhao B, Li L, Jiao Y, Luo M, Xu K, Hong Y, Cao JD, Zhang Y, Fang JL, Rong PJ. Transcutaneous auricular vagus nerve stimulation in treating post-stroke insomnia monitored by resting-state fMRI: The first case report. Brain Stimul. 2019 May-Jun;12(3):824-826. doi: 10.1016/j.brs.2019.02.016. Epub 2019 Feb 21. No abstract available.
PubMed 30871845Sun J, Li X, Zhou Y, Liu H, Ma C, Hao C, Liu S, Zhao J, Zhang X, Xiao X. Clinical advances in transcutaneous auricular vagus nerve stimulation for post-stroke disorders: state of the art and future perspectives. Front Neurol. 2025 Oct 31;16:1676727. doi: 10.3389/fneur.2025.1676727. eCollection 2025.
PubMed 41245869Niu S, Wu Q, Ding S, Wu L, Wang L, Shi Y. Comparison of three measures for insomnia in ischemic stroke patients: Pittsburgh sleep quality index, insomnia severity index, and Athens insomnia scale. Front Neurol. 2023 Aug 30;14:1118322. doi: 10.3389/fneur.2023.1118322. eCollection 2023.
PubMed 37712082Meng R, Huang M, Miller CB, Fong DYT, Gregory AM, Pakpour AH, Dzierzewski JM, Henry AL, Voinescu BI, Yang N, Ma H, Luo Y, Lau EYY, Spruyt K, Espie CA. Global perspectives on the Sleep Condition Indicator for DSM-5 insomnia disorder: a COSMIN and STARD systematic review of psychometric and diagnostic performance. BMC Med. 2025 Oct 8;23(1):542. doi: 10.1186/s12916-025-04285-7.
PubMed 41063190Liu W, Li G. The Latest Advances in Non-Invasive Neurostimulation for Insomnia: A Review. Nat Sci Sleep. 2025 May 15;17:947-957. doi: 10.2147/NSS.S501619. eCollection 2025.
PubMed 40395454Jackowska M, Koenig J, Vasendova V, Jandackova VK. A two-week course of transcutaneous vagal nerve stimulation improves global sleep: Findings from a randomised trial in community-dwelling adults. Auton Neurosci. 2022 Jul;240:102972. doi: 10.1016/j.autneu.2022.102972. Epub 2022 Mar 16.
PubMed 35364413de Oliveira HM, Gallo Ruelas M, Viana Diaz CA, Oliveira de Paula G, Fruett da Costa PR, Pilitsis JG. Transcutaneous Auricular Vagus Nerve Stimulation in Insomnia: A Systematic Review and Meta-Analysis. Neuromodulation. 2025 Dec;28(8):1332-1340. doi: 10.1016/j.neurom.2025.04.001. Epub 2025 May 5.
PubMed 40323248Gao L, Fan Y, Zhang N, Chen L. Transcutaneous Auricular Vagus Nerve Stimulation Paired With Exercise Training for Upper Limb Motor Function and Activities of Daily Living After Stroke: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2026 Mar 20:S0003-9993(26)00617-9. doi: 10.1016/j.apmr.2026.03.008. Online ahead of print.
PubMed 41865861Li L, Wang D, Pan H, Huang L, Sun X, He C, Wei Q. Non-invasive Vagus Nerve Stimulation in Cerebral Stroke: Current Status and Future Perspectives. Front Neurosci. 2022 Feb 16;16:820665. doi: 10.3389/fnins.2022.820665. eCollection 2022.
PubMed 35250458Fernandez-Mendoza J, Rodriguez-Munoz A, Vela-Bueno A, Olavarrieta-Bernardino S, Calhoun SL, Bixler EO, Vgontzas AN. The Spanish version of the Insomnia Severity Index: a confirmatory factor analysis. Sleep Med. 2012 Feb;13(2):207-10. doi: 10.1016/j.sleep.2011.06.019. Epub 2011 Dec 14.
PubMed 22172961Du L, He X, Xiong X, Zhang X, Jian Z, Yang Z. Vagus nerve stimulation in cerebral stroke: biological mechanisms, therapeutic modalities, clinical applications, and future directions. Neural Regen Res. 2024 Aug 1;19(8):1707-1717. doi: 10.4103/1673-5374.389365. Epub 2023 Nov 8.
PubMed 38103236Cai H, Wang XP, Yang GY. Sleep Disorders in Stroke: An Update on Management. Aging Dis. 2021 Apr 1;12(2):570-585. doi: 10.14336/AD.2020.0707. eCollection 2021 Apr.
PubMed 33815883Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vagus Nerve Stimulation on Improving Sleep for Individuals in an Inpatient Rehab Facility for Post-Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07858656
- Acronym / sponsor ID
- SleepVNS
- Keywords
- Vagal Nerve Stimulation, Post Acute Care, Stroke, Cerebrovascular Accident
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Casa Colina Hospital and Centers for HealthcareUniversity, hospital or other
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- 16 Oct 2027 (estimated)
- Study completion
- 16 Dec 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does using this device improve insomnia?
- 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
Detailed description
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 receive a handout on sleep hygiene. All participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. In line with previous studies investigating the impact of taVNS on other post-stroke symptoms, the intervention group 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 previously studied in stroke research (Li 2022) and allow for uniformity of application of the device between treatment and sham groups. The sham treatment group will be instructed in using the Parasym device the same way, however, their issued devices will include a sham earpiece that will prevent the transmission of taVNS. Reassessment of the ISI will be completed at 12-15 days, or earlier if the patient discharges prior to this timeline. A short 2-week taVNS program has been reported to have some effect on insomnia (Liu 2025) in a non-stroke population and this timeline has also been chosen as it coincides with the current typical length of stay for individuals post stroke in the acute rehabilitation unit.
All participants of the study will continue to receive the usual care for their individual rehabilitation program including therapy and medication interventions. Additional data will be collected beyond the screening tests including demographic information, stroke location, time since stroke, history of prior stroke, history of diabetes, NIH stroke scale on admission, record of medications that may impact sleep, consult to neurology service, use of respiratory devices on admission or during their rehab course (supplemental O2, CPAP, BiPAP), and GG and C scores of the IRF-PAI for mobility, self-care, and cognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transauricular Vagal Nerve Stimulation (taVNS) | Experimental | Device: transauricular Vagal Nerve StimulationParticipants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Reassessment of the ISI will be completed at 12-15 days, or earlier if the patient discharges prior to this timeline. These participants will continue to receive the usual care for their individual rehabilitation program including therapy and medication interventions. |
| Sham transauricular Vagal Nerve Stimulation (Sham taVNS) | Sham comparator | Device: Sham ComparatorParticipants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. For this group, their issued devices will include a sham earpiece that will prevent transmission of taVNS. The ISI will be re-assessed at 12-15 days, or earlier if the patient discharges prior to this timeline. Participants will continue to receive the usual care for their individual rehabilitation program, including therapy and medications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted to Casa Colina's acute rehabilitation service
- Diagnosis of ischemic stroke
- Age 18 years or older
- English or Spanish speaking
- Sufficient cognition to follow program instructions tested Mini Mental Exam (score >17/30)
Key exclusion criteria (5 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transauricular Vagal Nerve StimulationAll 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. | Device | transauricular Vagal Nerve Stimulation (taVNS) |
| Sham ComparatorAll 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. | Device | Sham transauricular Vagal Nerve Stimulation (Sham taVNS) |
Primary outcome
Insomnia Severity Index
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.
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.
1 secondary outcome
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Admission and Discharge Scores - GG and C sections
Time frame: Assessed within 48 hours of admission, re-assessed at discharge (with a typical length of stay of 12 to 15 days).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Background: PubMed 30871845Zhao B, Li L, Jiao Y, Luo M, Xu K, Hong Y, Cao JD, Zhang Y, Fang JL, Rong PJ. Transcutaneous auricular vagus nerve stimulation in treating post-stroke insomnia monitored by resting-state fMRI: The first case report. Brain Stimul. 2019 May-Jun;12(3):824-826. doi: 10.1016/j.brs.2019.02.016. Epub 2019 Feb 21. No abstract available.
- Background: PubMed 41245869Sun J, Li X, Zhou Y, Liu H, Ma C, Hao C, Liu S, Zhao J, Zhang X, Xiao X. Clinical advances in transcutaneous auricular vagus nerve stimulation for post-stroke disorders: state of the art and future perspectives. Front Neurol. 2025 Oct 31;16:1676727. doi: 10.3389/fneur.2025.1676727. eCollection 2025.
- Background: PubMed 37712082Niu S, Wu Q, Ding S, Wu L, Wang L, Shi Y. Comparison of three measures for insomnia in ischemic stroke patients: Pittsburgh sleep quality index, insomnia severity index, and Athens insomnia scale. Front Neurol. 2023 Aug 30;14:1118322. doi: 10.3389/fneur.2023.1118322. eCollection 2023.
- Background: PubMed 41063190Meng R, Huang M, Miller CB, Fong DYT, Gregory AM, Pakpour AH, Dzierzewski JM, Henry AL, Voinescu BI, Yang N, Ma H, Luo Y, Lau EYY, Spruyt K, Espie CA. Global perspectives on the Sleep Condition Indicator for DSM-5 insomnia disorder: a COSMIN and STARD systematic review of psychometric and diagnostic performance. BMC Med. 2025 Oct 8;23(1):542. doi: 10.1186/s12916-025-04285-7.
- Background: PubMed 40395454Liu W, Li G. The Latest Advances in Non-Invasive Neurostimulation for Insomnia: A Review. Nat Sci Sleep. 2025 May 15;17:947-957. doi: 10.2147/NSS.S501619. eCollection 2025.
- Background: PubMed 35364413Jackowska M, Koenig J, Vasendova V, Jandackova VK. A two-week course of transcutaneous vagal nerve stimulation improves global sleep: Findings from a randomised trial in community-dwelling adults. Auton Neurosci. 2022 Jul;240:102972. doi: 10.1016/j.autneu.2022.102972. Epub 2022 Mar 16.
- Background: PubMed 40323248de Oliveira HM, Gallo Ruelas M, Viana Diaz CA, Oliveira de Paula G, Fruett da Costa PR, Pilitsis JG. Transcutaneous Auricular Vagus Nerve Stimulation in Insomnia: A Systematic Review and Meta-Analysis. Neuromodulation. 2025 Dec;28(8):1332-1340. doi: 10.1016/j.neurom.2025.04.001. Epub 2025 May 5.
- Background: PubMed 41865861Gao L, Fan Y, Zhang N, Chen L. Transcutaneous Auricular Vagus Nerve Stimulation Paired With Exercise Training for Upper Limb Motor Function and Activities of Daily Living After Stroke: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2026 Mar 20:S0003-9993(26)00617-9. doi: 10.1016/j.apmr.2026.03.008. Online ahead of print.
- Background: PubMed 35250458Li L, Wang D, Pan H, Huang L, Sun X, He C, Wei Q. Non-invasive Vagus Nerve Stimulation in Cerebral Stroke: Current Status and Future Perspectives. Front Neurosci. 2022 Feb 16;16:820665. doi: 10.3389/fnins.2022.820665. eCollection 2022.
- Background: PubMed 22172961Fernandez-Mendoza J, Rodriguez-Munoz A, Vela-Bueno A, Olavarrieta-Bernardino S, Calhoun SL, Bixler EO, Vgontzas AN. The Spanish version of the Insomnia Severity Index: a confirmatory factor analysis. Sleep Med. 2012 Feb;13(2):207-10. doi: 10.1016/j.sleep.2011.06.019. Epub 2011 Dec 14.
- Background: PubMed 38103236Du L, He X, Xiong X, Zhang X, Jian Z, Yang Z. Vagus nerve stimulation in cerebral stroke: biological mechanisms, therapeutic modalities, clinical applications, and future directions. Neural Regen Res. 2024 Aug 1;19(8):1707-1717. doi: 10.4103/1673-5374.389365. Epub 2023 Nov 8.
- Background: PubMed 33815883Cai H, Wang XP, Yang GY. Sleep Disorders in Stroke: An Update on Management. Aging Dis. 2021 Apr 1;12(2):570-585. doi: 10.14336/AD.2020.0707. eCollection 2021 Apr.
- Individual participant dataSharing planned: No
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Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Rosario, PhD study director
Casa Colina Hospital and Centers for Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transauricular Vagal Nerve Stimulation in people with Stroke and Ischemic Cerebrovascular Accident, run by Casa Colina Hospital and Centers for Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie Yeseta, PT, DPT, NCS (9095967733 ext. 3111, myeseta@casacolina.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07858656, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.