Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

NCT05336760 | Recruiting

• 1 other identifier: URIS202201
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (7)

• Penetration-Aspiration Scale (PAS) change

  PAS is an 8-point scale used to determine swallowing safety. Levels 1 and 2 are considered safe, levels \>3 indicate penetration or aspiration and are considered unsafe.

  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

  YRSRS is a validated measure of swallowing efficiency using an image-based assessment to determine post-swallow pharyngeal residue: location and severity. It is assessed using a 5-point ordinal scale (from 1=0 % residue to 5=50 % residue).

  Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

• Iowa Oral Performance Instrument (IOPI) change

  IOPI is a device which measures tongue strength (in kilopascals; kPa) and endurance (in seconds) while the participant presses the bulb with the front or the base of their tongue to the hard palate.

  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

  MASA is a standard clinical swallowing assessment protocol administered by the speech-language therapist. Total score ranges from 38-200. Lower score indicates higher impairment.

  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

  EAT-10 is a validated self-administered dysphagia severity symptom survey including 10 items and a five-point scale (0=no problem to 4=sever problem). Higher total score indicates higher impairment.

  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

  SWAL-QoL is a 44-item standardised psychometric scale that measures swallowing-related QoL across 10 domains. Scores for each individual domain and a total SWAL-QoL score are calculated. Total score ranges from 0-100 (100 indicating the most favourable state).

  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

  The questionnaire comprises 10 questions. The participants specify their level of agreement on a five-point Likert-type scale (1=strongly disagree, 5= strongly agree).

  Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Secondary Outcomes (8)

• ALS Functional Rating Scale-Revised (ALSFRS-R) change

  Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

• Functional Oral Intake Scale (FOIS) change

  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

  Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

• BMI change

  Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

• Forced Vital Capacity (FVC) change

  Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)

Study Arms (2)

ALS Patients

Patients with confirmed amyotrophic lateral sclerosis.

Diagnostic Test: Iowa Oral Performance Instrument (IOPI); Diagnostic Test: Mann Assessment of Swallowing Ability (MASA); Diagnostic Test: Fiberoptic Endoscopic Evaluation of Swallowing; Diagnostic Test: Respiratory function measurements

Relatives

Close relatives of the patients included in the study.

Interventions

Iowa Oral Performance Instrument (IOPI) DIAGNOSTIC_TEST

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.

ALS Patients

Mann Assessment of Swallowing Ability (MASA) DIAGNOSTIC_TEST

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.

ALS Patients

Fiberoptic Endoscopic Evaluation of Swallowing DIAGNOSTIC_TEST

The subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie).

ALS Patients

Respiratory function measurements DIAGNOSTIC_TEST

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.

ALS Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include adult ALS patients able to visit the study site for in-person procedures every 3 months, and their close relatives.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead
• University Medical Centre Ljubljana: collaborator

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Blaž Koritnik, MD, PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Metka Moharić, MD, PhD

CONTACT

+386 1 4758441; metka.moharic@ir-rs.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 20, 2022
• Study Start: January 1, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)