Amyotrophic Lateral SclerosisALSDPEGNCT05336760
Dysphagia, QoL and Attitudes Towards PEG in ALS Patients
An observational study of Amyotrophic Lateral Sclerosis, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Iowa Oral Performance Instrument (IOPI), Mann Assessment of Swallowing Ability (MASA) and Fiberoptic Endoscopic Evaluation of Swallowing
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Blaž Koritnik, MD, PhD, +386 1 5221501, blaz.koritnik@kclj.si
About this study
Official title: Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis
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.
Read the 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
- Being tested
- Iowa Oral Performance Instrument (IOPI), Mann Assessment of Swallowing Ability (MASA), Fiberoptic Endoscopic Evaluation of Swallowing, Respiratory function measurements
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Fiberoptic Endoscopic Evaluation of SwallowingDiagnostic test
The subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie).
Respiratory function measurementsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| ALS Patients | Patients with confirmed amyotrophic lateral sclerosis. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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
ALSFRS-R is a 12-tem ALS-specific assessment of global functioning using a five-point scale (0=not able, 4= normal ability), with 48 points representing normal function.
Measured: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Functional Oral Intake Scale (FOIS) change
FOIS is a validated 7-point scale demonstrating an individual's ability of daily oral food intake (1=no oral intake, 7=total oral intake with no restrictions).
Measured: 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
DOSS is a 7-point scale that rates the functional severity of dysphagia based on objective assessment and provides information on diet recommendations, independence level and type of nutrition necessary (level 7=normal swallowing function, level 1=severe dysphagia).
Measured: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
BMI change
Body mass index (in kg/m^2)
Measured: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Forced Vital Capacity (FVC) change
Standard clinical respiratory assessment of FVC (in %)
Measured: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Peak Cough Flow (PCF) change
Standard clinical respiratory assessment of PCF (in L/min)
Measured: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Maximal Inspiratory Pressure (MIP) change
Standard clinical respiratory assessment of MIP (in cmH2)
Measured: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Maximal Expiratory Pressure (MEP) change
Standard clinical respiratory assessment of MEP (in cmH2)
Measured: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jan 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Rehabilitation Institute, Republic of Slovenia
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Responsible party
- Sponsor
- Investigators
- Blaž Koritnik, MD, PhD, Principal investigator, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336760
- Sponsor's protocol ID
- URIS202201
- Acronym
- ALSDPEG
- Status last verified
- Jun 2026
- First submitted
- 16 Mar 2022
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT05336760
- Acronym / sponsor ID
- ALSDPEG / URIS202201
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Rehabilitation Institute, Republic of SloveniaUniversity, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS Patients | – | 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 measurementsPatients with confirmed amyotrophic lateral sclerosis. |
| Relatives | – | –Close relatives of the patients included in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | ALS Patients |
| 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 | ALS Patients |
| Fiberoptic Endoscopic Evaluation of SwallowingThe subjects will ingest up to 10 boluses ranging in thickness and volume (from thin to extremely-thick and a cookie). | Diagnostic test | ALS Patients |
| Respiratory function measurementsRespiratory 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. | Diagnostic test | ALS Patients |
Primary outcome
Penetration-Aspiration Scale (PAS) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
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.
Yale Residue Severity Rating Scale (YRSRS) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
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).
Iowa Oral Performance Instrument (IOPI) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
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.
Mann Assessment of Swallowing Ability (MASA) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
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.
Eating Assessment Tool 10 (EAT-10) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
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.
Swallowing Quality of Life Questionnaire (SWAL-QoL) change
Time frame: At baseline and every 3 months until PEG insertion, 3 and 6 months after PEG insertion
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).
Questionnaire on Attitudes Toward PEG Tube Feeding and Insertion Procedure change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
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).
8 secondary outcomes
ALS Functional Rating Scale-Revised (ALSFRS-R) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Functional Oral Intake Scale (FOIS) change
Time frame: 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
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
BMI change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Forced Vital Capacity (FVC) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Peak Cough Flow (PCF) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Maximal Inspiratory Pressure (MIP) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Maximal Expiratory Pressure (MEP) change
Time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Blaž Koritnik, MD, PhD principal investigator
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by University Rehabilitation Institute, Republic of Slovenia at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Metka Moharić, MD, PhD (+386 1 4758441, metka.moharic@ir-rs.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration Scale (PAS) change (time frame: Difference between baseline and PEG insertion (usually in 6-25 months after diagnosis, maximum follow-up 30 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.