[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Spark Biomedical, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,57,90,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100618061","delivering-tan-to-reduce-hmb-the-luna-study-100618061",false,"NCT07326722","Delivering tAN to Reduce HMB: The LUNA Study","Delivering Transcutaneous Auricular Neurostimulation to Reduce Heavy Menstrual Bleeding: The LUNA Study","LUNA","Inclusion Criteria:\n\n1. Regularly menstruating female aged 14-45 years at time of screening\n2. History of menorrhagia as assessed by the Menorrhagia Screening Tool\n3. Stable\u002Fconsistent use of current non-hormonal medications and supplements for the past three months, willingness to continue use for duration of study, and not start any new medications or homeopathic remedies\n4. Reliable access to an internet-enabled device to complete required questionnaires that is compatible with the study application (iOS 18 and Android 15 or greater)\n5. Willingness to consistently use only study-provided menstrual products throughout duration of the study\n6. Participant PBAC scores are ≥150 for both baseline menstruation months\n\nExclusion Criteria:\n\n1. Pregnancy within three months of enrollment\n2. Lactating at the time of enrollment\n3. Typical length of menstruation greater than 14 days\n4. Antifibrinolytic (i.e. tranexamic acid; Lysteda) use within 14 days of enrollment\n5. Known acquired bleeding disorder\n6. Known severe bleeding disorder (participants with mild von Willebrand disease will be eligible to participate in the study)\n7. Use of anticoagulants (i.e. Warfarin, Coumadin, etc.) including platelet inhibitors for 14 days prior to enrollment\n8. Use of prescriptive pain medications and\u002For use of the following analgesics: Aspirin, naproxen (Aleve), or magnesium salicylate (Doan's) during the study\n9. Use of the copper intrauterine device within the past three months\n10. Structural cause of heavy menstrual bleeding (e.g. fibroids, polyps, etc.) in medical records\n11. Documented thrombocytopenia within the last 12 months (platelet count ≤100,000 per microliter of blood) in medical records\n12. Any use of continuous hormone therapies (e.g., IUD, etc.) within three months prior to enrollment\n13. Use of hormone therapies that have not followed a standard 21\u002F7 dosing regimen for at least six months prior to enrollment\n14. Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months\n15. Participant has a history of epileptic seizures within the past 12 months\n16. Participant has a history of neurologic diseases (i.e. stroke, brain tumor, cerebrovascular, etc.)\n17. Participant has a history traumatic brain injury within the past 12 months\n18. Participant has had a splenectomy\n19. Participant has presence of devices (e.g., pacemakers, cochlear prostheses, neurostimulators) and\u002For uses other neurostimulators\n20. Participant has abnormal ear anatomy or ear infection present\n21. Participant has previously used auricular neurostimulation for any clinical indication\n22. Participant is currently or plans to be enrolled in another clinical trial during enrollment\n23. Participant is a ward of the state\n24. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial","FEMALE","14 Years","45 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","The LUNA study is a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial in participants with heavy menstrual bleeding of no known structural cause. The study includes two age-based cohorts: adolescents aged 14-21 and adults aged 22-45. Participants in both cohorts will be randomized to receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) and the auriculotemporal nerve (ATN), or sham stimulation. Participants will be enrolled into the study over the course of five consecutive menstrual cycles. All study activities will occur remotely and in addition to participants' typical treatment for HMB (as allowed by the eligibility criteria).\n\nDuring the first two consecutive menstrual cycles (M1 - M2, \"Baseline Phase\"), no tAN treatment will be delivered. Participants will estimate blood loss using the Pictorial Bleeding Assessment Chart (PBAC), and menstrual cramp pain will be assessed with a Numerical Rating Scale (NRS), daily throughout the duration of the menstruation phase of their two baseline menstrual cycles. Menstrual symptoms will be assessed using the Cox Menstrual Symptom Scale (CMSS) and a general quality of life assessment will be conducted on the final day of menstruation using the RAND Short-Form 36 (RAND-36). Menstrual-related quality of life assessments will also be conducted on the final day of each menstruation using the Menstrual Bleeding Questionnaire (MBQ) in the adult cohort, and the adolescent version (aMBQ) in the adolescent cohort.\n\nDuring the following three consecutive menstruations (M3 - M5, \"Treatment Phase\"), participants will self-administer one 2-hour sham or active tAN session daily, beginning Day 1 of menstruation through the final day of menstruation in each menstrual cycle. Blood loss (via the PBAC) and menstrual cramp pain (via the NRS) will be assessed daily throughout the duration of each menstruation. Quality of life will be assessed with the CMSS, RAND-36, and the MBQ (adults) or aMBQ (adolescents) on the final day of each menstruation. A device usability survey will be completed at the end of M3 and M5. Participants will exit the study after the final day of M5.",[28],"Heavy Menstrual Bleeding",[30,31,32,33,34,35,36,37,38,39,40,41,42,43],"transcutaneous auricular neurostimulation","tAN","heavy menstrual bleeding","HMB","adolescent heavy menstrual bleeding","aHMB","neurostimulation","vagus nerve stimulation","hemostasis","menstruation","menstrual cycle","blood loss","PBAC","Menorrhagia","RECRUITING","2026-06-01",{"date":47,"type":48},"2026-06-02","ACTUAL",{"date":50,"type":48},"2026-03-06",{"date":52,"type":22},"2027-08-31",{"name":54,"class":55},"Spark Biomedical, Inc.","INDUSTRY",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":69,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":56},"100614566","tan-for-substance-use-disorder-100614566","NCT07281261","tAN for Substance Use Disorder","Study of Transcutaneous Auricular Neurostimulation as a Treatment for Substance Use Disorder","Inclusion Criteria:\n\n1. Male or female (evenly recruited) aged 18-64 years old\n2. Meeting DSM-5 criteria of moderate or above AUD at screening using the structured clinical interview for DSM-5 (SCID-5)\n3. Demonstration of at least moderate risk of alcohol use at screening using the WHO-ASSIST\n4. Demonstration of high risk for moderate to severe alcohol withdrawal syndrome (Prediction of Alcohol Withdrawal Severity Scale \\[PAWSS\\] \\> 4 at admission)\n5. Demonstration of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised \\[CIWA-Ar\\] ≥ 8 at screening)\n6. Positive urine test for alcohol at screening\n7. Be able to provide written informed consent\n8. Female subjects must be non-nursing and not pregnant\n9. Meet the MRI safety screening form provided by the Center for Advanced MR Imaging (CAMRI) at BCM.\n\nExclusion Criteria:\n\n1. In the opinion of the clinician and the research team at admission, be expected to fail to complete the study protocol due to probably relocation from The Menninger Clinic area or not tolerable to receive tAN\n2. Current use of tobacco\n3. Is pregnant or nursing\n4. Contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.)\n5. Do not meet the pre-screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI) at BCM","ALL","18 Years","64 Years",{"count":68,"type":22},20,[25],"The study will involve a 5-day tAN treatment to attenuate alcohol withdrawal syndrome (AWS) and alter resting state functional connectivity (RSFC) between OFC and striatum in patients with alcohol use disorder (AUD). Enrolled participants will wear the tAN device on-site (at The Menninger Clinic) for the 5-day detox treatment period. Participants with AUD will be single-blinded randomized into 2 groups - a treatment group (active tAN) and a placebo group (sham tAN). Each group will consist of five separate time points - admission, screening, baseline, tAN treatment, and post tAN treatment. Clinical measures collected before, during, and after treatment will include alcohol withdrawal severity, craving, benzodiazepine usage, and assessments of depression and suicidal behaviors. Participants will undergo MRI scans before and after the treatment period to assess changes in brain connectivity and their relationship to clinical outcomes.",[72,73,74,75],"Alcohol Use Disorder","Alcohol Abuse","Substance Use Disorders","Substance Use Disorders Alcohol Use Withdrawal State",[77,72,78,79,31,80,81,82,83],"Alcohol","Substance Use Disorder","Transcutaneous Auricular Neurostimulation","Neurostimulation","Vagus Nerve Stimulation","Auricular Neurostimulation","Transcutaneous",{"date":47,"type":48},{"date":86,"type":48},"2026-01-28",{"date":88,"type":22},"2026-08-31",{"name":54,"class":55},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":64,"minAge":65,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":23,"phases":99,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":56},"100601350","tan-for-first-responders-100601350","NCT07109349","tAN for First Responders","Effect of Transcutaneous Auricular Neurostimulation on Mental Wellness and Resiliency for First Responders: A Pilot Trial","Inclusion Criteria:\n\n1. Participant is currently employed in a first responder position\n2. Age ≥ 18 years\n3. Reliable access to an internet-enabled device to complete required questionnaires\n4. GAD-7 score ≥ 5\n\nExclusion Criteria:\n\n1. Participant has a history of epileptic seizures\n2. Participant has a history of neurologic diseases or traumatic brain injury\n3. Participant has presence of devices (e.g., pacemakers, cochlear prostheses or implants, neurostimulators)\n4. Participant has abnormal left ear anatomy or ear infection present\n5. Participant has auditory impairment of the left ear (ruptured eardrum, deafness, tinnitus, etc.)\n6. Participant is currently enrolled in another interventional trial\n7. Women of childbearing potential, not using adequate contraception as per the investigator's judgement\n8. Females who are pregnant or lactating\n9. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial",{"count":98,"type":22},30,[25],"This study is designed as an open label, single arm, decentralized clinical study in which first responders will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled in the study over the course of eight weeks (56 days).\n\nParticipants will respond to daily and weekly questionnaires regarding mood, stress, sleep, energy\u002Ffatigue, and burnout. Each week, participants will complete consolidated online questionnaires (intended to last no longer than 15 minutes) comprised of the Perceived Stress Short-Form (PSS-4), Well-Being Index (WHO-5), Mini-Z Burnout (5-item), PROMS Sleep Disturbance (PROMIS-SD), GAD-7 (every 2 weeks), and Perceived Stress (PSS-10; monthly). The PSS-10 will replace the PSS-4 on Days 0, 28, and 56.\n\nNo tAN treatment will be delivered during the Baseline Period (days between Study Introduction and Day 0). Participants will complete the weekly set of questionnaires (\"Weekly Questionnaires\") on Day 0. Participants will be recommended to complete the daily set of questionnaires (\"Daily Questionnaires \") on the other days of the Baseline Period.\n\nOn Days 1 - 28, participants will self-administer one session of one to two hours of tAN therapy each day. Participants will be recommended to complete the daily tAN session post-shift prior to sleep. Weekly Questionnaires will be completed by participants on Study Days 0, 7, 14, 21, 28, 35, 42, 49, and 56. Participants will be recommended to complete Daily Questionnaires on all other study days, up to Day 28. Daily Questionnaires will not be required to be completed by participants. Daily tAN sessions and Daily Questionnaires will cease after Day 28. Participants will complete a Study Satisfaction Questionnaire with the Weekly Questionnaires on Day 56.\n\nFollowing Day 56, participants will schedule a Study Exit Interview with the Research Coordinator.",[102,103],"Mental Fatigue","Mental Stress",[105,31,79,106,80,107,108,109],"Mental resilience","Vagus nerve stimulation","First responders","taVNS","Police officer",{"date":47,"type":48},{"date":112,"type":48},"2025-09-10",{"date":114,"type":22},"2026-07-20",{"name":54,"class":55},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":64,"minAge":65,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100553549","sensing-physiological-symptoms-of-opioid-withdrawal-and-cravings-in-patients-with-opioid-use-disorder-100553549","NCT06487533","Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder","Inclusion Criteria\n\n1. Participant has a recent history of opioid dependence; prescription or non-prescription\n2. Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)\n3. Participant is between 18 and 50 years of age\n4. Participant is English proficient\n5. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements\n6. Participant is willing to wear wearable sensors for 14 days\n\nExclusion Criteria\n\n1. Participant presents current evidence of an uncontrolled and\u002For clinically significant medical condition or psychiatric condition\n2. Participant has a history of epileptic seizures\n3. Participant has a history of neurological diseases or traumatic brain injury\n4. Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation\n5. Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering \"yes\" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial\n6. Females who are pregnant or lactating\n7. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial","50 Years",{"count":68,"type":22},"OBSERVATIONAL","The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.",[127,128],"Opioid Withdrawal","Opioid Use Disorder",[130,131,132,133,134],"Physiological Signals","Opioid","Detoxification","Cravings","Autonomic Nervous System",{"date":47,"type":48},{"date":137,"type":48},"2025-02-19",{"date":139,"type":22},"2027-05-31",{"name":54,"class":55},2,""]