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Recruiting NCT05336760

Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

— Observational Amyotrophic Lateral Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Iowa Oral Performance Instrument (IOPI), Mann Assessment of Swallowing Ability (MASA), Fiberoptic Endoscopic Evaluation of Swallowing, Respiratory function measurements.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Slovenia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis

Overview

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.

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 course of the disease. It will take maximum of 60 minutes to fully evaluate the swallowing function and complete the questionnaires. The evaluation procedure will be repeated every 3 months until PEG tube insertion, which will allow us to closely monitor the swallowing function in a relation to attitudes toward PEG and QoL. The data obtained from this study should contribute significantly to the knowledge of QoL in ALS patients with dysphagia, and it will allow for a comparison of QoL in ALS patients with and without PEG tube. This study will also expand the understanding of attitudes in ALS patients and their relatives toward PEG, and the impact of those attitudes on the decision-making process.

Interventions

  • Diagnostic test Iowa Oral Performance Instrument (IOPI)
    IOPI measures the peak pressure of the tongue strength and endurance using a disposable bulb placed on a hard palate behind the front teeth or at the base of the tongue. The participants will be asked to press the bulb with their tongue with maximum pressure, three times. To measure the endurance, the participants will be asked to hold the pressure for as long as they can.
  • Diagnostic test Mann Assessment of Swallowing Ability (MASA)
    MASA is a standard clinical swallowing assessment protocol including general patient examination, on-the-outside visible signs of oral preparatory and transportation phase and pharyngeal phase of swallowing function.
  • Diagnostic test Fiberoptic Endoscopic Evaluation of Swallowing
    The subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie).
  • Diagnostic test Respiratory function measurements
    Respiratory function measurements will include forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP), all expressed in percentage of predicted values. Conventional methods of testing will be applied.

Primary outcome measures

  • Penetration-Aspiration Scale (PAS) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Yale Residue Severity Rating Scale (YRSRS) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Iowa Oral Performance Instrument (IOPI) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Mann Assessment of Swallowing Ability (MASA) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Eating Assessment Tool 10 (EAT-10) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Swallowing Quality of Life Questionnaire (SWAL-QoL) change [Time frame: At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion]
  • Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
Secondary outcome measures (8)
  • ALS Functional Rating Scale-Revised (ALSFRS-R) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Functional Oral Intake Scale (FOIS) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Dysphagia Outcome and Severity Scale (DOSS) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • BMI change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Forced Vital Capacity (FVC) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Peak Cough Flow (PCF) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Maximal Inspiratory Pressure (MIP) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]
  • Maximal Expiratory Pressure (MEP) change [Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Slovenia · 1 center
  • University Medical Centre Ljubljana — Ljubljana

Identifiers

NCT: NCT05336760 · URIS202201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗