[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03418350":3,"trial-entities:NCT03418350":73,"trial-summary:NCT03418350":78},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":32,"sex":33,"minimum_age":34,"maximum_age":35,"healthy_volunteers":36,"eligibility_criteria":37,"std_ages":46,"locations":49,"central_contacts":64,"overall_officials":67,"references":71,"see_also_links":72},"NCT03418350","HS-3130","The Role of Laryngopharyngeal Reflux in IPF","RECRUITING","2026-12","2024-11","2024-11-14","2018-08-01","National Jewish Health","OTHER",null,"The primary objective of this study is to show that the Supraglottic Index (SGI) is an easily-collected index that accurately identifies the presence and severity of laryngopharyngeal reflux (LPF) in idiopathic pulmonary fibrosis (IPF).","The study team hypothesizes the SGI will correlate more strongly with measures of IPF severity (at baseline and over time) than gastroesophageal reflux (GER) data derived from the esophageal detector channels of a pH\u002Fimpedance probe.",[18,19],"IPF","Reflux",[],"OBSERVATIONAL",[],{"count":24,"type":25},60,"ESTIMATED",[],[28],{"measure":29,"description":30,"timeFrame":31},"The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis.","Correlation between the supraglottic index and forced vital capacity. The supraglottic index is an index derived by assigning scores for edema and erythema of five supraglottic structures (epiglottis, false cords, arytenoids, posterior commissure, piriform recess) as viewed through a fiber-optic scope. Scores range from 0-22, with higher scores indicating more severe LPR.","6 months",[],"ALL","40 Years","95 Years",false,{"inclusion":38,"exclusion":44,"raw_text":45},[39,40,41,42,43],"Diagnosis of IPF","Age 40-95","Able to read, speak, and understand English","If subjects are currently taking medication for reflux or GERD, they much be on a stable does for at least 4 weeks prior to consent.","Pregnant females",[],"Inclusion Criteria:\n\n* Diagnosis of IPF\n* Age 40-95\n* Able to read, speak, and understand English\n* If subjects are currently taking medication for reflux or GERD, they much be on a stable does for at least 4 weeks prior to consent.\n\nExclusion Criteria:\n\n* Patients who do not meet all inclusion criteria\n* Pregnant females",[47,48],"ADULT","OLDER_ADULT",[50],{"facility":12,"status":7,"city":51,"state":52,"zip":53,"country":54,"contacts":55,"geoPoint":61},"Denver","Colorado","80206","United States",[56],{"name":57,"role":58,"phone":59,"email":60},"Tara Churney, MPH","CONTACT","303-398-1996","ILDresearch@njhealth.org",{"lat":62,"lon":63},39.73915,-104.9847,[65],{"name":66,"role":58,"phone":59,"email":60},"Matthew Koslow, MPH",[68],{"name":69,"affiliation":12,"role":70},"Matthew Koslow, DO","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":74,"biomarkers":77},[75,76],"Idiopathic Pulmonary Fibrosis","Laryngopharyngeal reflux",[],{"nct_id":4,"found":79,"summary":80,"prompt_version":90},true,{"design":81,"status":82,"heading":83,"summary":84,"follow_up":85,"word_count":86,"commitments":87,"compensation":88,"drugs_mentioned":89},"This is an observational study, meaning researchers will observe participants without providing specific interventions. It plans to include 60 participants aged 40 to 95.","completed","Understanding Reflux in Idiopathic Pulmonary Fibrosis (IPF)","This study is looking at the role of laryngopharyngeal reflux (LPR), a type of reflux where stomach acid comes up into the throat, in people with Idiopathic Pulmonary Fibrosis (IPF). Researchers want to see if a measurement called the Supraglottic Index (SGI) can accurately identify LPR and how severe it is in individuals with IPF. They believe the SGI will better show the link between reflux and IPF severity compared to other reflux tests. You may be able to join if you are 40 to 95 years old, have an IPF diagnosis, and can speak and understand English. If you take reflux medication, it needs to be at a stable dose for at least four weeks. The study aims to enroll 60 participants.","The primary endpoint, the supraglottic index, is measured at 6 months, suggesting a follow-up period of at least that long.",123,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]