About this trial
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
Qualifiers
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
Disqualifiers
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
signs of probable cognitive deterioration or dementia at enrollment
Trial design
Treatments tested in this trial
- Iowa Oral Performance Instrument (IOPI)
- Mann Assessment of Swallowing Ability (MASA)
- Fiberoptic Endoscopic Evaluation of Swallowing
- Respiratory function measurements
Treatment groups
Sponsors and collaborators
University Rehabilitation Institute, Republic of Slovenia
Lead sponsor
University Medical Centre Ljubljana
Collaborator