Monitoring swallowing function and quality of life in ALS patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.