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 | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-01-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Blaž Koritnik, MD, PhD
PRINCIPAL INVESTIGATOR
University Medical Centre Ljubljana
Frequently Asked Questions
Who can join the NCT05336760 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05336760 currently recruiting?
Yes, NCT05336760 is actively recruiting participants. Contact the research team at metka.moharic@ir-rs.si for enrollment information.
Where is the NCT05336760 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT05336760 clinical trial?
NCT05336760 is sponsored by University Rehabilitation Institute, Republic of Slovenia. The principal investigator is Blaž Koritnik, MD, PhD at University Medical Centre Ljubljana. The trial plans to enroll 60 participants.
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