Monitoring swallowing function and quality of life in ALS patients
Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis
This study looks at how swallowing problems affect the quality of life for people with ALS and how they feel about getting a feeding tube.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Rehabilitation Institute, Republic of Slovenia Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT05336760 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with Amyotrophic Lateral Sclerosis (ALS) to monitor the deterioration of their swallowing function and its impact on their quality of life (QoL) and attitudes towards percutaneous endoscopic gastrostomy (PEG) tube insertion. Patients will undergo evaluations every three months, which will include assessments of swallowing ability and completion of questionnaires regarding their QoL and attitudes towards PEG. The study aims to provide valuable insights into how dysphagia affects ALS patients and their decision-making regarding feeding interventions. The findings could enhance understanding of the QoL differences between ALS patients with and without PEG tubes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with ALS who can attend follow-up visits every three months.
Not a fit: Patients with significant cognitive deterioration or other illnesses affecting swallowing function independently of ALS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of dysphagia in ALS patients and inform better decision-making regarding PEG tube placement.
How similar studies have performed: While the specific focus on QoL and attitudes towards PEG in ALS patients is less explored, similar studies on dysphagia management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ljubljana
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Principal investigator: Blaž Koritnik, MD, PhD — University Medical Centre Ljubljana
- Study coordinator: Metka Moharić, MD, PhD
- Email: metka.moharic@ir-rs.si
- Phone: +386 1 4758441
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.