Dysphagia, QoL and Attitudes Towards PEG in ALS Patients

NCT ID: NCT05336760

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2026-03-31

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.

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ALS Patients

Patients with confirmed amyotrophic lateral sclerosis.

Iowa Oral Performance Instrument (IOPI)

Intervention Type: 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.

Mann Assessment of Swallowing Ability (MASA)

Intervention Type: 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.

Fiberoptic Endoscopic Evaluation of Swallowing

Intervention Type: DIAGNOSTIC_TEST

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

Respiratory function measurements

Intervention Type: 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.

Relatives

Close relatives of the patients included in the study.

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

• at least 18 years of age

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: collaborator

University Rehabilitation Institute, Republic of Slovenia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Blaž Koritnik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Locations

University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Metka Moharić, MD, PhD

Role: CONTACT

metka.moharic@ir-rs.si

+386 1 4758441

Facility Contacts

Blaž Koritnik, MD, PhD

Role: primary

blaz.koritnik@kclj.si

+386 1 5221501

Other Identifiers

URIS202201

Identifier Type: -

Identifier Source: org_study_id