RecruitingNCT05336760

Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

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

Sponsor

University Rehabilitation Institute, Republic of Slovenia

Enrollment

60 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

Amyotrophic Lateral Sclerosis

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

Min Age: 18 Years

Inclusion Criteria5

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
at least 18 years of age

Exclusion Criteria3

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
signs of probable cognitive deterioration or dementia at enrollment

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Interventions

DIAGNOSTIC_TESTIowa 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_TESTMann 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_TESTFiberoptic 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_TESTRespiratory 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.