[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cough-hypersensitivity-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cough-hypersensitivity-syndrome":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100633286","effects-of-energy-versus-mechanical-surgical-devices-on-postoperative-cough-100633286",false,"NCT07524712","Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough","Preliminary Study on the Associated Mechanisms Between Surgical Instruments and Postoperative Cough","ENERGY-COUGH","Inclusion Criteria:\n\n* Adult patients scheduled to undergo elective video-assisted thoracoscopic surgery (VATS) for partial resection of the right lung and lymph node sampling between 2025 and 2026;\n* Preoperative examination shows that the maximum diameter of the pulmonary lesion is 2 cm or less (T1), with no hilar or mediastinal lymph node metastasis and no evidence of distant metastasis (M0);\n* ASA grade I-III.\n\nExclusion Criteria:\n\n* With a respiratory infection in the past 4 weeks, and with a history of chronic cough, chronic bronchitis, bronchiectasis, asthma, rhinitis, gastroesophageal reflux disease, or allergic rhinitis syndrome;\n* Using angiotensin-converting enzyme inhibitors (ACEI);\n* Severe heart disease;\n* Having a history of lung surgery.","ALL","18 Years",{"count":20,"type":21},248,"ESTIMATED","INTERVENTIONAL",[24],"NA","Numerous current studies have indicated that transecting the pulmonary plexus nerve as a routine step in radical lung cancer surgery is an independent risk factor for cough hypersensitivity (CH). However, there are significant disagreements in the thoracic surgery community regarding the strategy for managing the vagus pulmonary plexus, primarily because key clinical issues remain unresolved: How do surgical procedures affect the occurrence and development of CH? And how can these procedures be improved?\n\nA large number of published studies have only analyzed \"where to cut\" while neglecting the surgical issue of \"how to cut\". Even with a high level of evidence, the conclusions remain contradictory. This is because doctors' preferences and changes in supply conditions can influence the selection of instruments. Differences in the energy of the instruments can lead to varying degrees and scopes of vagus nerve degeneration and collateral damage to the sympathetic pulmonary plexus, while CH is regulated by both the sympathetic and parasympathetic nervous systems.\n\nThis project intends to explore the correlation between the selection of surgical instruments and the occurrence and development of postoperative CH at the clinical level, providing a reference for optimizing surgical methods and preventing and treating postoperative CH after lung surgery.\n\nThe specific research objectives are: to clarify the correlation through a randomized controlled trial, comparing the patterns and changes in the occurrence and development of postoperative CH between two groups of patients whose autonomic nerve pulmonary plexus was transected using energy-based instruments versus mechanical methods.\n\nOptimize the surgical procedure: Based on the above results, propose a safe, effective, and feasible surgical method to reduce intraoperative damage, prevent postoperative CH, and improve patients' quality of life.\n\nKey problems to be solved: How do surgical operations affect the occurrence and development of CH? How can improvements be made?\n\n1. Clinical issues:\n\n   ① Do energy-based instruments (causing thermal damage, etc.) and mechanical transection (causing physical damage), which lead to varying degrees of vagus nerve injury and collateral sympathetic nerve damage, affect the occurrence and development of postoperative cough hypersensitivity (CH)?\n\n   ② How to optimize surgical operations to reduce the incidence of postoperative CH and improve patients' quality of life?\n2. Correlation mechanisms: How do different instruments and energy modes affect the pathophysiology of nerve injury, degeneration, and repair, and what are the correlation patterns and mechanisms between these and the occurrence and development of CH?",[27,28],"Postoperative Cough","Cough Hypersensitivity Syndrome",[30,31,32,33,34,35],"postoperative cough","persistent cough","surgical instruments","cough hypersensitivity","vagus pulmonary plexus","vagus nerve","NOT_YET_RECRUITING","2026-05-02",{"date":39,"type":40},"2026-05-07","ACTUAL",{"date":42,"type":21},"2026-09-01",{"date":44,"type":21},"2028-09-01",{"name":46,"class":47},"Tongji Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":80},"100615124","phase-4-a-2x2-factorial-randomized-open-label-trial-to-evaluate-neuromodulators-and-cough-control-therapy-in-patients-with-refractory-or-unexplained-chronic-cough-100615124","NCT07288528","A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough","A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough (FORTITUDE)","FORTITUDE","Inclusion Criteria:\n\n1. Adults (≥18 years old) with either:\n2. Refractory chronic cough (RCC), defined as having one or more identifiable causes of cough (asthma, allergic rhinitis, and\u002For GERD), but with previous trials of treatment targeting the underlying condition leading to no cough resolution; OR\n3. Unexplained chronic cough (UCC), defined as having a cough lasting \\>8 weeks with (i) a normal chest X-ray\u002FCT in the last 5 years and since the onset of chronic cough; (ii) FEV1 and FVC ≥80% predicted or \\>lower limit of normal (LLN); (iii) FEV1\u002FFVC ≥0.7 or \\>LLN; (iv) no evidence of asthma; and (vi) no regular symptoms of nasal\u002Freflux disease.\n\nExclusion Criteria:\n\n1. Those who, in the opinion of the investigator, have previously tried low-dose morphine, pregabalin, and\u002For CCT with full intervention fidelity for the treatment of RCC\u002FUCC;\n2. Are currently taking morphine or pregabalin for the treatment of any indication (i.e., RCC\u002FUCC or chronic pain);\\*\n3. Are currently taking other centrally-acting medication (i.e., gabapentin, amitriptyline, dextromethorphan) for the treatment of any indication (i.e., RCC\u002FUCC, seizures, or depression);\\*\n4. Have a history of opioid or substance abuse that, in the opinion of the investigator, may interfere with the conduct of the study;\n5. Are a current smoker, or ex-smoker with a \\>20 pack-year history who have abstained from smoking for \\\u003C6 months;\n6. Have cough due to angiotensin-converting enzyme inhibitor use;\n7. Have symptoms of an upper respiratory infection within the last month that have not resolved;\n8. Had an asthma exacerbation within the last month that requires an increase or start of an oral corticosteroid;\n9. Have other primary pulmonary disorders, including pulmonary embolism, pulmonary hypertension, lung cancer, cystic fibrosis, radiologically-proven emphysema, interstitial lung disease, or severe bronchiectasis;\n10. Have language, memory, cognitive, or psychiatric issues that may prevent optimal participation;\n11. Have creatinine clearance \\\u003C15 mL\u002Fmin, including individuals with end-stage renal disease who require hemodialysis or peritoneal dialysis;\n12. Have any other condition that, in the opinion of the qualified investigator, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant;\n13. Have participated in another clinical trial of an investigational medicinal product within 30 days;\n14. Pregnant or breastfeeding; or\n15. Females of child-bearing potential who:\n\n    1. Do not agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of 3 months.\n    2. Acceptable methods of birth control include oral contraceptives, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant, double-barrier method, intrauterine devices, non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s), vasectomy of partner at least 6 months prior to screening.\n    3. Females who are not of child-bearing potential will be defined as females who have undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening.\n\n       * Participants taking any of the above medications at baseline will only be eligible if they are willing and medically able to safely discontinue them at least 2 weeks prior to the first study visit. Eligibility will be confirmed by the local study investigator prior to enrolment.",{"count":58,"type":21},124,[60],"PHASE4","The FORTITUDE trial will provide head-to-head evidence on the benefits and harms of two commonly prescribed neuromodulators (low-dose morphine and pregabalin), the effectiveness of a virtual cough control therapy, exploratory assessment of potential synergy in combining these interventions, and the long-term outcomes of these treatments in patients with refractory or unexplained chronic cough.",[63,64,65,28,66],"Cough","Refractory Chronic Cough","Unexplained Chronic Cough","Chronic Cough",[63,66,68,69,70,64,65],"Morphine","Pregabalin","Non-Pharmacologic Therapy","2025-12-04",{"date":73,"type":40},"2025-12-17",{"date":75,"type":21},"2026-04-01",{"date":77,"type":21},"2029-07-01",{"name":79,"class":47},"McMaster University",5]