[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07508059":3,"trial-entities:NCT07508059":84,"trial-summary:NCT07508059":87},{"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":20,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":51,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":60,"locations":62,"central_contacts":70,"overall_officials":79,"references":82,"see_also_links":83},"NCT07508059","25-01669","High Resolution Pharyngeal Manometry (HRPM) Biofeedback","Assessing the Impact of Biofeedback on Task Performance With Swallowing Maneuvers in Healthy Young Adults Using High Resolution Pharyngeal Manometry (HRPM)","RECRUITING","2027-05-01","2026-03","2026-08-21","2026-08-19","NYU Langone Health","OTHER",false,"The purpose of this study is to quantify the added benefit of visual biofeedback from High Resolution Pharyngeal Manometry (HRPM) for swallowing rehabilitation. Primary aims including assessing changes in swallowing biomechanics (pressure generation, timing) during swallow maneuvers with and without HRPM visual biofeedback. Secondary aim includes participant attitudes related to visual biofeedback and the experience of HRPM.",null,[19],"Healthy",[21],"Swallow","INTERVENTIONAL",[24],"NA",{"count":26,"type":27},50,"ESTIMATED",[29,34],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Swallowing Maneuvers","Swallows will include 5 regular-effort saliva swallows (+\u002F- visual biofeedback), 5 effortful saliva swallows (+\u002F- visual biofeedback), 5 mendelsohn maneuver swallows (+\u002F- visual biofeedback), and 5 masako or tongue hold maneuver swallows (+\u002F- visual biofeedback).",[33],"Swallowing Maneuvers with and without HRPM Biofeedback",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DIAGNOSTIC_TEST","High Resolution Pharyngeal Manometry (HRPM)","A diagnostic tool using a catheter with closely spaced sensors to measure pressures and timing within the pharynx and upper esophageal sphincter (UES) during swallowing",[33],[40],"Solar GI",[42,46,49],{"measure":43,"description":44,"timeFrame":45},"Change in pharyngeal contractile integral (PhCI) (mmHg) with and without visual biofeedback via HRPM","Pharyngeal contractile integral, a product of mean pharyngeal contractile amplitude, length, and duration. Low PhCI (\\\u003C 100-150 mmHg·s·cm): Indicates hypo-contractility or weakness while High PhCI (\\> 200-300+ mmHg·s·cm): Represents stronger contraction strength","Baseline (without HRPM), with HRPM (up to 2 minutes)",{"measure":47,"description":48,"timeFrame":45},"Change in pharyngoesophageal Segment (PES) opening duration (ms) with and without visual biofeedback via HRPM","Measures the duration of Upper Esophageal Sphincter (UES) opening in milliseconds. Short Duration (\\\u003C300ms) correlates with upper esophageal sphincter dysfunction, reduced laryngeal elevation, and poor pharyngeal contraction.",{"measure":50,"timeFrame":45},"Change in PES pressure with visual biofeedback via HRPM with and without visual biofeedback via HRPM",[],"ALL","18 Years","40 Years",true,{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. Participants must be independent community dwelling adults.\n2. Participants must be between the ages of 18-40 years old.\n3. Willingness to consent and participate in the study procedures.\n4. No reported dysphagia or difficulty swallowing evidenced by an EAT-10 Score \\\u003C3.\n\nExclusion Criteria:\n\n1. Known structural or neurological causes of dysphagia (e.g., stroke, brain injury, or head\u002Fneck cancer).\n2. Recent or remote history of swallowing therapy; familiarity with swallowing maneuvers from relevant coursework as applicable (i.e., speech language pathology students).",[61],"ADULT",[63],{"facility":13,"status":8,"city":64,"state":64,"zip":65,"country":66,"geoPoint":67},"New York","10016","United States",{"lat":68,"lon":69},40.71427,-74.00597,[71,76],{"name":72,"role":73,"phone":74,"email":75},"Sonja Molfenter","CONTACT","212-992-7694","Smm16@nyu.edu",{"name":77,"role":73,"email":78},"Claire Crossman","Cmc9512@nyu.edu",[80],{"name":72,"affiliation":13,"role":81},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":85,"biomarkers":86},[19],[],{"nct_id":4,"found":55,"summary":88,"prompt_version":98},{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an interventional study planning to enroll 50 healthy participants. It is not specified if it is randomized or blinded.","completed","High Resolution Pharyngeal Manometry (HRPM) Biofeedback Study","This study is looking at how visual feedback from High Resolution Pharyngeal Manometry (HRPM) can help improve swallowing. HRPM is a diagnostic tool that uses a small tube with sensors to measure pressures and timing in your throat during swallowing. Researchers want to see if seeing these measurements in real-time (visual biofeedback) helps healthy adults aged 18-40 perform swallowing exercises better. They will measure changes in how strongly your throat muscles contract and how long a part of your throat called the pharyngoesophageal segment (PES) opens, both with and without this visual feedback. The study also aims to understand participants' feelings about using HRPM and visual biofeedback. Currently, the recruitment status is unclear, and the study plans to enroll 50 healthy individuals.","Participants will be followed for up to 2 minutes during the HRPM measurements.",122,"You would perform various swallowing maneuvers, such as regular-effort, effortful, Mendelsohn, and Masako\u002Ftongue hold swallows, both with and without visual biofeedback from the HRPM device. These measurements will be taken at baseline and for up to 2 minutes with HRPM.","Not stated in the trial record.",[36],"v2"]