Status:
RECRUITING
Dysphagia, QoL and Attitudes Towards PEG in ALS Patients
Lead Sponsor:
University Rehabilitation Institute, Republic of Slovenia
Collaborating Sponsors:
University Medical Centre Ljubljana
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05336760
Start Date
January 1 2023
End Date
March 31 2026
Last Update
October 15 2024
Active Locations (1)
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1
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000