Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Rehabilitation Institute, Republic of Slovenia

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Rehabilitation Institute, Republic of Slovenia

Lead sponsor

University Medical Centre Ljubljana

Collaborator