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Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

NCT05336760 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    collaborator OTHER

  • University Rehabilitation Institute, Republic of Slovenia

    lead OTHER

Principal Investigators

  • Blaž Koritnik, MD, PhD · University Medical Centre Ljubljana

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Slovenia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05336760 on ClinicalTrials.gov