Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke
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).
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Marie Yeseta, PT, DPT, NCS
- Telefonnummer: 3111 9095967733
- E-Mail: myeseta@casacolina.org
Studieren Sie die Kontaktsicherung
- Name: Hannah Cone, PT, DPT, NCS
- Telefonnummer: 3111 9095967733
- E-Mail: HCone@casacolina.org
Studienorte
-
-
California
-
Pomona, California, Vereinigte Staaten, 91767
- Casa Colina Hospital and Centers for Healthcare
-
Kontakt:
- Niko Fullmer
- Telefonnummer: 2220 9095967733
- E-Mail: NFullmer@casacolina.org
-
Kontakt:
- Emily Rosario, PhD
- Telefonnummer: 3316 9095967733
- E-Mail: ERosario@casacolina.org
-
Hauptermittler:
- Marie Yeseta, PT, DPT, NCS
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: transauricular Vagal Nerve Stimulation (taVNS)
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. |
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. |
|
Schein-Komparator: Sham transauricular Vagal Nerve Stimulation (Sham taVNS)
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 to the same parameters as for the experimental group, however his device will include a sham earpiece that will prevent the transmission of taVNS. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Insomnia Severity Index
Zeitfenster: 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. |
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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) Admission and Discharge Scores - GG and C sections
Zeitfenster: Assessed within 48 hours of admission, re-assessed at discharge (with a typical length of stay of 12 to 15 days).
|
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. |
Assessed within 48 hours of admission, re-assessed at discharge (with a typical length of stay of 12 to 15 days).
|
Mitarbeiter und Ermittler
Ermittler
- Studienleiter: Emily Rosario, PhD, Casa Colina Hospital and Centers for Healthcare
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- SleepVNS
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .