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

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Fiberoptic Endoscopic Evaluation of Swallowing, Iowa Oral Performance Instrument (IOPI), and others for people with amyotrophic lateral sclerosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University Medical Centre Ljubljana

Ljubljana, Slovenia

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NCT05336760


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