[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neurovalens Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100589569","electrical-vestibular-nerve-stimulation-vens-as-a-treatment-for-improving-sleep-in-visually-impaired-patients-100589569",false,"NCT06956118","Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Improving Sleep in Visually Impaired Patients","Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients With Visual Impairment","Inclusion Criteria:\n\n1. Signed Informed Consent\n2. Male or female, age ≥ 20 years and ≤ 60 years at the time of signing informed consent\n3. PSQI score ≥ 5 at screening and baseline\n4. Symptoms of sleep disorder lasting ≥ 3 months at the time of screening\n5. Severely Sight Impaired (defined as a visual acuity of \\\u003C 6\u002F60 but ≥3\u002F60 at 6 meters) OR blind (defined as a visual acuity of \\\u003C3\u002F60 at 6 metres).\n6. Participants must be accompanied by a family member or carer during the enrollment and initial study visit. For subsequent visits, accompaniment is encouraged; if a companion is unavailable, assistance will be provided by study staff or trained personnel.\n7. Can speak\u002Fread Hindi or English\n8. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device per the study protocol\n9. Ability and willingness to attend the clinic for 30-minute stimulation sessions 5 days per week for the duration of the treatment period (4-weeks).\n10. Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact sleep e.g. dietary or exercise changes\n11. Agreement not to use prescription, or over the counter, sleep medications for the duration of the trial and haven't for 4 weeks before the trial\n12. Agreement not to use sleep trackers for the duration of the study (e.g. sleep app smart watches such as Fitbits)\n13. Agree not to travel across multiple time-zones during the duration of the study\n14. Agree to maintain a familiar sleeping environment\u002Froutine throughout the study and will not discontinue or begin treatment with new devices, used while sleeping, during the study (e.g. CPAP machines)\n\n    \\-\n\nExclusion Criteria:\n\n1. A PSQI score \\\u003C 5 at screening\n2. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.\n3. Previous diagnosis of a chronic viral infection, for example hepatitis or HIV\n4. A history of stroke or severe head injury requiring intensive care or neurosurgery\n5. Diagnosis of a current psychotic disorder\n6. Suffering from a current characterized depressive episode\n7. Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.).\n8. Pregnancy or breast-feeding or intends to become pregnant\n9. History of epilepsy\n10. History of active migraines with aura\n11. History of head injury requiring intensive care or neurosurgery\n12. History of diagnosed cognitive impairment such as Alzheimer's disease\u002Fdementia\n13. History of bipolar, psychotic or substance use disorders\n14. Regular use (more than twice a month) of antihistamine medication within the last 6 month. The subject can opt to switch to Fexofenadine (non-drowsy) and may enroll after a wash-out period of 2 weeks.\n15. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)\n16. A diagnosis of myelofibrosis or a myelodysplastic syndrome.\n17. Previous use of any VeNS device\n18. Participation in other clinical trials sponsored by Neurovalens or other insomnia studies\n19. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.\n20. History of vestibular dysfunction or other inner ear disease\n21. Member of the same household is currently or has previously participated in clinical study sponsored by Neurovalens\n\n    \\-","ALL","18 Years","80 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Trial title: Effectiveness of Electrical Vestibular Nerve Stimulation in the Improvement of Sleep in Patients with Visual Impairment.\n\nThis pilot clinical trial is testing whether a device called VeNS (vestibular nerve stimulation) can safely and effectively improve sleep in adults who are visually impaired.\n\nThe study will compare the active VeNS device to a sham (inactive) device. Participants will use the device under supervision for 30 minutes a day over 4 weeks, followed by a 4-week observation period. Researchers will assess sleep improvements, safety, and how acceptable and easy the treatment is for participants.\n\nAllocation: Randomized to either active device or control device usage.\n\nEndpoint classification: Efficacy Study\n\nIntervention Model: Parallel Assignment in 1:1 active to control allocation\n\nSample size: The aim is to recruit a total of up to 60 participants. The study will last 8 weeks in total for each subject.",[27,28,29],"Sleep Quality","Quality of Lifte","Non-24 Sleep-Wake Disorder",[31,32,33,29,34,35,36],"sleep","sleep quality","insomnia","quality of life","vestibular stimulation","neurostimulation","RECRUITING","2026-04-13",{"date":40,"type":41},"2026-04-16","ACTUAL",{"date":43,"type":41},"2025-12-01",{"date":45,"type":21},"2026-06",{"name":47,"class":48},"Neurovalens Ltd.","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":5},"100552203","electrical-vestibular-nerve-stimulation-vens-as-a-treatment-for-major-depressive-disorder-mdd-100552203","NCT06470035","Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD)","A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study","Inclusion Criteria:\n\n1. Signed Informed Consent\n2. Adults, (US ≥ 22 years and ≤ 80 years, UK ≥ 18 years and ≤ 80 years) male or female at the time of signing informed consent\n3. Beck's Depression Inventory-ll (BDI-ll) score of ≥ 14 at Screening\n4. Established diagnosis of depression as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI)\n5. A Generalized Anxiety Disorder (GAD-7) score \\<10 at screening\n6. On anti-depressant medication to treat depression (participant must only be on one Selective Serotonin or Norepinephrine Reuptake Inhibitor (SSRI\u002FSNRI) for at least 1 year prior to baseline visit, and no longer than 5 years)\n7. Stable dose of current prescribed antidepressant (SSRI\u002FSNRI) medication to treat depression, 3 months prior to baseline appointment\n8. Maintain a stable prescribed medication and\u002For treatment regime to treat depression for the duration of the trial\n9. No change in regular medication for the duration of the trial (unless directed by a health care provider).\n10. Can speak \u002F read English\n11. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device per the study protocol\n12. Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial\n13. Access to Wi-Fi for the duration of the study\n14. Access to a computer, laptop, iPad, tablet or smartphone (to complete study visits and complete online study questionnaires)\n15. Willingness to use a video calling platform to conduct remote study visits\n16. Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact mood e.g. dietary , exercise changes\n17. Agree not to begin any complimentary or alternative therapies that may affect your mood during the time on the study e.g use of mental health apps, CBT\n\nExclusion Criteria:\n\n1. Risk of persistent self-harm or suicide as confirmed by the Columbia Suicide Severity Rating Scale (CSSRS)\n2. Diagnosis or history of bipolar disorder\n3. History of or a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis\n4. Diagnosis of substance use disorder within the past 12 months or current substance use dependence\n5. Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days\n6. Female who is pregnant or breast-feeding\n7. History of diagnosed cognitive impairment \u002F disorder such as delirium or dementia\n8. Previous or current diagnosis of a chronic viral infection, for example hepatitis or HIV (potential damage to vestibular system, known as vestibular neuropathy).\n9. History of stroke or head injury requiring intensive care or neurosurgery (potential damage to neurological pathways affected by vestibular stimulation)\n10. Presence of permanently implanted batterypowered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)\n11. History of epilepsy\n12. History of severe tinnitus or vertigo\n13. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.\n14. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)\n15. History of vestibular dysfunction or another inner ear disease\n16. Regular use (more than twice a month) of antihistamine medication within the last 6 months. The subject can opt to switch to Fexofenadine (non-drowsy) and may enrol after a wash-out period of 2 weeks\n17. Diagnosis of active migraines\n18. Previous use of Modius device or any VeNS device\n19. Participation in other clinical trials sponsored by Neurovalens\n20. Participation in any other depression studies at the time of enrolment and throughout this study duration\n21. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.\n22. Failure to use device daily during trial participation (no more than 14 consecutive days usage drop without reasonable explanation)\n23. Persistent failure to comply with study protocol and procedures",{"count":58,"type":21},170,[24],"Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Major Depressive Disorder (MDD) - Modius Mood Study\n\nThe aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating major depressive disorder(MDD) , as compared to a sham control.\n\nAllocation: Randomized to either active device or control device usage.\n\nEndpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation",[62,63],"Major Depressive Disorder \\(MDD","Depressive Disorder, Major",[65,66,67,68],"VeNS","Depression","MDD","Vestibular stimulation","NOT_YET_RECRUITING","2024-08-07",{"date":72,"type":41},"2024-08-09",{"date":74,"type":21},"2025-04",{"date":76,"type":21},"2027-04",{"name":47,"class":48},""]