The Impact of Vagus Nerve Stimulation on Improving Sleep for Individuals in an Inpatient Rehab Facility for Post-Acute Ischemic Stroke
Sponsor study identifier
interventional
52
1 country
1
Study Start
October 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 29, 2026
Actual (reported)October 5, 2026
Actual (reported)October 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Admission and Discharge Scores - GG and C sections
Assessed within 48 hours of admission, re-assessed at discharge (with a typical length of stay of 12 to 15 days).
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.
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.
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.
Casa Colina Hospital and Centers for Healthcare
Pomona, California, 91767, United States
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.
Sun 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.
Emily Rosario, PhD
Casa Colina Hospital and Centers for Healthcare
First Submitted
September 29, 2026
First Posted
October 5, 2026
Study Start
October 16, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 16, 2027
EEG Changes and DNA Markers Related to taVNS in Stroke Patients: a Preliminary Study
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Niu 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.
Meng 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.
Liu 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.
Jackowska 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.
de 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.
Gao 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.
Li 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.
Fernandez-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.
Du 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.
Cai 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.
Bastien 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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-10
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