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Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

Recruitingn/aAges 18 Years - anyAllUniversity Rehabilitation Institute, Republic of …
NCT05336760 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria for patients: * 18 years of age or older * diagnosis of ALS * follow-up at University Medical Centre Ljubljana, Division of Neurophysiology, every 3 months * be able to visit the study site for in-person procedures every 3 months Inclusion Criteria for relatives: * at least 18 years of age Exclusion Criteria for patients: * co-existing illness or disorder that could influence the swallowing function independently of the ALS diagnosis * clinically significant cognitive deterioration or dementia at enrollment, as determined by the ALS study neurologist Exclusion criteria for relatives: * signs of probable cognitive deterioration or dementia at enrollment
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What it tests

  • Iowa Oral Performance Instrument (IOPI)
  • Mann Assessment of Swallowing Ability (MASA)
  • Fiberoptic Endoscopic Evaluation of Swallowing
  • Respiratory function measurements
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Where

1 site
University Medical Centre Ljubljana
Ljubljana, Slovenia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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