NCT05336760 Dysphagia, QoL and Attitudes Towards PEG in ALS Patients
| NCT ID | NCT05336760 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Rehabilitation Institute, Republic of Slovenia |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2026-03-31 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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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