[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100465135":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":68,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":10,"enrollmentInfo":80,"targetDuration":10,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":10,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University Rehabilitation Institute, Republic of Slovenia","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"ALS Patients",null,"Patients with confirmed amyotrophic lateral sclerosis.",[13,14,15,16],"Diagnostic Test: Iowa Oral Performance Instrument (IOPI)","Diagnostic Test: Mann Assessment of Swallowing Ability (MASA)","Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing","Diagnostic Test: Respiratory function measurements",{"label":18,"type":10,"description":19,"interventionNames":10},"Relatives","Close relatives of the patients included in the study.",[21,26,30,34],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":10},"DIAGNOSTIC_TEST","Iowa Oral Performance Instrument (IOPI)","IOPI measures the peak pressure of the tongue strength and endurance using a disposable bulb placed on a hard palate behind the front teeth or at the base of the tongue. The participants will be asked to press the bulb with their tongue with maximum pressure, three times. To measure the endurance, the participants will be asked to hold the pressure for as long as they can.",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"Mann Assessment of Swallowing Ability (MASA)","MASA is a standard clinical swallowing assessment protocol including general patient examination, on-the-outside visible signs of oral preparatory and transportation phase and pharyngeal phase of swallowing function.",[9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Fiberoptic Endoscopic Evaluation of Swallowing","The subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie).",[9],{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Respiratory function measurements","Respiratory function measurements will include forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP), all expressed in percentage of predicted values. Conventional methods of testing will be applied.",[9],[39],{"name":40,"affiliation":41,"role":42},"Blaž Koritnik, MD, PhD","University Medical Centre Ljubljana","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":10,"email":48},"Metka Moharić, MD, PhD","CONTACT","+386 1 4758441","metka.moharic@ir-rs.si",[50],{"facility":41,"status":51,"city":52,"state":10,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":57,"coordinates":58},"Point",[59,60],14.50513,46.05108,{"lat":60,"lon":59},[63],{"name":40,"role":46,"phone":64,"phoneExt":10,"email":65},"+386 1 5221501","blaz.koritnik@kclj.si",{"type":67,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[69],{"name":41,"class":6},"100465135","dysphagia-qol-and-attitudes-towards-peg-in-als-patients-100465135",false,"NCT05336760","Dysphagia, QoL and Attitudes Towards PEG in ALS Patients","Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis","ALSDPEG","Inclusion Criteria for patients:\n\n* 18 years of age or older\n* diagnosis of ALS\n* follow-up at University Medical Centre Ljubljana, Division of Neurophysiology, every 3 months\n* be able to visit the study site for in-person procedures every 3 months\n\nInclusion Criteria for relatives:\n\n* at least 18 years of age\n\nExclusion Criteria for patients:\n\n* co-existing illness or disorder that could influence the swallowing function independently of the ALS diagnosis\n* clinically significant cognitive deterioration or dementia at enrollment, as determined by the ALS study neurologist\n\nExclusion criteria for relatives:\n\n* signs of probable cognitive deterioration or dementia at enrollment","ALL","18 Years",{"count":81,"type":82},60,"ESTIMATED","OBSERVATIONAL","In Amyotrophic Lateral Sclerosis, dysphagia has a high incidence. With deterioration of swallowing function, percutaneous endoscopic gastrostomy (PEG) tube is recommended to ensure sufficient and safe oral intake. Dysphagia and PEG placement alter quality of life (QoL). However, QoL and attitudes toward PEG remain largely unexplored. The purpose of this study is to monitor the swallowing function in relationship to QoL and attitudes toward PEG tube insertion and feeding.",[86],"Amyotrophic Lateral Sclerosis","2026-06-11",{"date":89,"type":90},"2026-06-15","ACTUAL",{"date":92,"type":90},"2023-01-01",{"date":94,"type":82},"2026-09-30",{"name":5,"class":6},1]