[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07251140":3,"trial-entities:NCT07251140":91,"trial-summary:NCT07251140":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":48,"eligibility_criteria":49,"std_ages":59,"locations":62,"central_contacts":84,"overall_officials":86,"references":89,"see_also_links":90},"NCT07251140","STUDY00009053","Dysphagia Study Using Novel Microphone Device","Novel Acoustic Biopatch for the Investigation of Dysphagia","RECRUITING","2026-09-30","2025-11","2025-11-26","2025-10-12","Emory University","OTHER",true,"This study aims to collect swallowing acoustics with a novel non-invasive wearable surface microphone device during routine work-up, videofluoroscopic swallow study (VFSS), of patients with dysphagia (swallowing trouble). The collected microphone data will be analyzed to find the pattern of abnormal swallowing by machine learning algorithm.","Difficulty swallowing is a very common laryngeal problem affecting many individuals. This study aims to optimize and validate a device to detect dysphagia without invasive procedures. This is an investigational nanomembrane patch, which is a thin film, that will be attached to the subject's chin to check the activity of their muscles. The patch is designed to determine the movement of their muscles and acoustics while swallowing.\n\nThis is a prospective cohort study. Dysphagic individuals with stroke visiting Emory University Hospital and Emory Midtown hospital will be asked to participate in the study. Individuals above the age of 40 years will be recruited. The study will be explained in detail to the individuals. After which a written signed consent will be obtained by research personnel before performing any research procedure. The biopatch will be placed and calibrated in dysphagic individuals at the time of performing a barium swallowing test. The collected medical (dysphagia questionnaire) data and demographic data will be collected and saved in Emory REDCap.",[19,20],"Dysphagia","Stroke",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},50,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Microphone device","* An investigational nanomembrane patch, which is a thin film, is designed to collect acoustics while swallowing.\n* The Microphone is also placed between the thyroid and cricoid cartilages to record swallowing acoustics.",[35],"Novel Acoustic Biopatch for the Investigation of Dysphagia Cohort",[37],{"measure":38,"description":39,"timeFrame":40},"Normalized Surface Acoustic Swallowing Signal","Surface acoustic swallowing signals will be collected using a wearable biopatch containing a microphone, placed on study participants. Raw acoustic data will be recorded in voltage and subsequently normalized against background acoustic levels, resulting in a unitless measure expressed in arbitrary units (a.u.).","Up to 30 min post-intervention",[42],{"measure":43,"description":44,"timeFrame":40},"Time to apply device to patients","Time to apply the device to patients will be recorded in minutes.","ALL","40 Years","85 Years",false,{"inclusion":50,"exclusion":56,"raw_text":58},[51,52,53,54,55],"Diagnosis or suspected stroke","Stroke with additional neurological disorders","Age between 40 and 85","Male and Female","Scheduled to VFSS due to suspected dysphagia, which is determined by bedside water swallowing test and EAT-10 questionnaire as a standard of care.",[57],"Head and neck cancer treatment history","Inclusion Criteria:\n\n* Diagnosis or suspected stroke\n* Stroke with additional neurological disorders\n* Age between 40 and 85\n* Male and Female\n* Scheduled to VFSS due to suspected dysphagia, which is determined by bedside water swallowing test and EAT-10 questionnaire as a standard of care.\n\nExclusion Criteria:\n\n* BMI\\>35 as an exclusion criteria to recruit participants due to limited transmission of acoustics through increased subcutaneous fat.\n* Head and neck cancer treatment history",[60,61],"ADULT","OLDER_ADULT",[63,78],{"facility":64,"status":8,"city":65,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":75},"Emory University Hospital Midtown","Atlanta","Georgia","30308","United States",[70],{"name":71,"role":72,"phone":73,"email":74},"Hyojung Choo, PhD","CONTACT","404-727-3727","hyojung.choo@emory.edu",{"lat":76,"lon":77},33.749,-84.38798,{"facility":79,"status":8,"city":65,"state":66,"zip":80,"country":68,"contacts":81,"geoPoint":83},"Emory University Hospital","30322",[82],{"name":71,"role":72,"phone":73,"email":74},{"lat":76,"lon":77},[85],{"name":71,"role":72,"phone":73,"email":74},[87],{"name":71,"affiliation":13,"role":88},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":92,"biomarkers":93},[19,20],[],{"nct_id":4,"found":15,"summary":95,"prompt_version":104},{"design":96,"status":97,"heading":6,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study with a planned enrollment of 50 participants. It is a prospective cohort study, meaning participants are followed forward in time.","completed","This study is looking for people aged 40 to 85 who have difficulty swallowing (dysphagia) due to a stroke. Researchers are testing a new, non-invasive microphone device, which is a thin film patch, designed to be worn on your chin or between your thyroid and cricoid cartilages. This device collects sounds made while you swallow during a routine videofluoroscopic swallow study (VFSS), which is a special X-ray to watch you swallow. The goal is to use this sound data and machine learning to better understand patterns of abnormal swallowing. The main thing they'll be measuring is the normalized surface acoustic swallowing signal up to 30 minutes after the device is used.","The primary measurement will be taken up to 30 minutes post-intervention.",111,"You would have the investigational nanomembrane patch placed and calibrated during your scheduled barium swallowing test. Medical and demographic information will also be collected.","Not stated in the trial record.",[32],"v2"]