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Clinical Trial Summary

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.


Clinical Trial Description

The purpose of this study is to monitor the deterioration of swallowing function in ALS patient population, and to explore its impact on QoL and attitudes toward PEG tube insertion and feeding in the course of the disease. It will take maximum of 60 minutes to fully evaluate the swallowing function and complete the questionnaires. The evaluation procedure will be repeated every 3 months until PEG tube insertion, which will allow us to closely monitor the swallowing function in a relation to attitudes toward PEG and QoL. The data obtained from this study should contribute significantly to the knowledge of QoL in ALS patients with dysphagia, and it will allow for a comparison of QoL in ALS patients with and without PEG tube. This study will also expand the understanding of attitudes in ALS patients and their relatives toward PEG, and the impact of those attitudes on the decision-making process. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05336760
Study type Observational
Source University Rehabilitation Institute, Republic of Slovenia
Contact Metka Moharic, MD, PhD
Phone +386 1 4758441
Email metka.moharic@ir-rs.si
Status Recruiting
Phase
Start date January 1, 2023
Completion date March 31, 2026

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