Amyotrophic Lateral SclerosisNCT07178574
Polish Version Dyspnea in Amyotrophic Lateral Sclerosis
An observational study of Amyotrophic Lateral Sclerosis, run by Jakub Antczak.
Trial summary
Amyotrophic lateral sclerosis is a fatal disease with progressive degeneration of central and peripheral motor neurons. Weakness of pharyngeal and respiratory muscles lead to dyspnea, which is present in up to 80% of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Jun 2028
- 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: Patients who suffer of amyotrophic lateral sclerosis (named also motor neuron disease, Lou Gehrig's disease or Charcot's disease) and have breathlessness or shortness of breath due to this disease. Eligible patients cannot have problems with breathing because of other conditions such as heart or lung diseases. They also must not suffer from mental problems severe enough to cause problems with understanding of scales and questionaires used in the study.
Who may be able to join
- Diagnosis of definite ALS, or probable ALS or probable, laboratory supported ALS according to revised Escorial criteria [Brooks et al. 2000].
- Complaining of dyspnea on exertion, or dyspnea at rest, or orthopnea without evidence of pulmonary or cardiac causes of dyspnea.
Who cannot join
- Cognitive impairment severe enough to interfere with study process.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of Polish Language Version of Dyspnea in Amyotrophic Lateral Sclerosis Outcome Measure
Amyotrophic lateral sclerosis is a fatal disease with progressive degeneration of central and peripheral motor neurons. Weakness of pharyngeal and respiratory muscles lead to dyspnea, which is present in up to 80% of patients. Dyspnea in Amyotrophic Lateral Sclerosis (DALS-15) is a questionnaire designed to measure the severity of dyspnea. DALS-15 was originally created in German language. The aim of this study is to validate the Polish-language version of DALS-15.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a fatal disease with progressive degeneration of central and peripheral motor neurons with death occurring usually three to five years after onset. Weakness of pharyngeal and respiratory muscles lead to chronic dyspnea, which is present in up to 80% of patients and which contributes to anxiety, depression, and significant decrease of the quality of life. Moreover, these symptoms, along with daytime sleepiness or apathy may mask the dyspnea itself and the patient may stay unaware of increasing respiratory insufficiency. Recognizing the time of the onset of respiratory insufficiency is on the other hand important for the planning of respiratory assistance therapy, which in ALS includes continuous positive airway pressure, as well as the noninvasive and the invasive ventilation. Dyspnea in amyotrophic lateral sclerosis (DALS-15) is a questionnaire designed to measure the severity of dyspnea. DALS-15 was originally created in German language. It is a 15-item tool. Particular items are descriptions of the severity of subjective dyspnea or refer to daily consequences of dyspnea such as avoiding the sleep in supine position or refer to the situations when dyspnea may occur, such as physical effort. Each item may be answered with "never", "occasionally" or "often", which are scored 0, 1 and 2, respectively. The total, arithmetical score, which ranges from 0 to 30 is then transformed according to the provided table into an interval score, which reflects the impact of dyspnea more accurately. The original DALS-15 showed excellent psychometric properties and has been already validated for Turkish language. The aim of this study is to validate the Polish-language version of DALS-15.
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, dyspnea, DALS-15, validation, Polish-language version
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Patients with diagnosis of ALS and with complaining of dyspnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Convergent Validity - Modified Borg Dyspnea Scale upright
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of Polish-language version of Modified Borg Dyspnea Scale in upright position. The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of of Polish-language version of Modified Borg Dyspnea Scale ranges between 0 and 10 with higher scores meaning a worse outcome.
Measured: Through study completion, an average of 1 year.
Convergent Validity - Modified Borg Dyspnea Scale supine
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of Polish-language version of Modified Borg Dyspnea Scale in supine position. The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of of Polish-language version of Modified Borg Dyspnea Scale ranges between 0 and 10 with higher scores meaning a worse outcome.
Measured: Through study completion, an average of 1 year.
Reliability
Reliability will be tested by calculating the correlation between Polish language version of DALS-15 scores from the 1st and 2nd administration in the randomly selected subgroup of patients. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome.
Measured: Through study completion, an average of 1 year.
Internal Consistency
Consistency between particular items of Polish language version of DALS-15 will be evaluated using Cronbach alfa test. The score of the Polish language version of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (3)
Convergent Validity - ALSFRS-r
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of the respiratory part (items 10-12) of Polish-language version of the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R). The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of the respiratory part of ALSFRS-R ranges between 0 and 12 with higher scores meaning a better outcome.
Measured: Through study completion, an average of 1 year.
Impact of fatigue on quality of life - index
Correlation between DALS-15 and the index score of EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The index score of EQ-5D-5L questionnaire ranges between -0.59 to 1 with higher scores indicating better outcome.
Measured: Through study completion, an average of 1 year.
Impact of fatigue on quality of life - visual analogue scale
Correlation between DALS-15 and the visual analogue scale score of EQ-5D-5L (EuroQol-5 dimension) questionnaire. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The visual analogue scale score of EQ-5D-5L (EuroQol-5 dimension) questionnaire ranges between 0 to 100 with higher scores indicating better outcome.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jakub Antczak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jakub Antczak, Jagiellonian University
- Investigators
- Jakub M Antczak, MD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178574
- Sponsor's protocol ID
- Jagiellonian U76
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed, the scans of collected questionnaires will be available upon request sent to the e-mail: jakub.antczak@uj.edu.pl
Publications
Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.
PubMed 11464847
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Polish Language Version of Dyspnea in Amyotrophic Lateral Sclerosis Outcome Measure
- ClinicalTrials.gov ID
- NCT07178574
- Acronym / sponsor ID
- Jagiellonian U76
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, dyspnea, DALS-15, validation, Polish-language version
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jakub AntczakUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Sep 2025 (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.
Amyotrophic lateral sclerosis is a fatal disease with progressive degeneration of central and peripheral motor neurons. Weakness of pharyngeal and respiratory muscles lead to dyspnea, which is present in up to 80% of patients. Dyspnea in Amyotrophic Lateral Sclerosis (DALS-15) is a questionnaire designed to measure the severity of dyspnea. DALS-15 was originally created in German language. The aim of this study is to validate the Polish-language version of DALS-15.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a fatal disease with progressive degeneration of central and peripheral motor neurons with death occurring usually three to five years after onset. Weakness of pharyngeal and respiratory muscles lead to chronic dyspnea, which is present in up to 80% of patients and which contributes to anxiety, depression, and significant decrease of the quality of life. Moreover, these symptoms, along with daytime sleepiness or apathy may mask the dyspnea itself and the patient may stay unaware of increasing respiratory insufficiency. Recognizing the time of the onset of respiratory insufficiency is on the other hand important for the planning of respiratory assistance therapy, which in ALS includes continuous positive airway pressure, as well as the noninvasive and the invasive ventilation. Dyspnea in amyotrophic lateral sclerosis (DALS-15) is a questionnaire designed to measure the severity of dyspnea. DALS-15 was originally created in German language. It is a 15-item tool. Particular items are descriptions of the severity of subjective dyspnea or refer to daily consequences of dyspnea such as avoiding the sleep in supine position or refer to the situations when dyspnea may occur, such as physical effort. Each item may be answered with "never", "occasionally" or "often", which are scored 0, 1 and 2, respectively. The total, arithmetical score, which ranges from 0 to 30 is then transformed according to the provided table into an interval score, which reflects the impact of dyspnea more accurately. The original DALS-15 showed excellent psychometric properties and has been already validated for Turkish language. The aim of this study is to validate the Polish-language version of DALS-15.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | –Patients with diagnosis of ALS and with complaining of dyspnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who suffer of amyotrophic lateral sclerosis (named also motor neuron disease, Lou Gehrig's disease or Charcot's disease) and have breathlessness or shortness of breath due to this disease. Eligible patients cannot have problems with breathing because of other conditions such as heart or lung diseases. They also must not suffer from mental problems severe enough to cause problems with understanding of scales and questionaires used in the study.
Key inclusion criteria (2 listed)
- Diagnosis of definite ALS, or probable ALS or probable, laboratory supported ALS according to revised Escorial criteria [Brooks et al. 2000].
- Complaining of dyspnea on exertion, or dyspnea at rest, or orthopnea without evidence of pulmonary or cardiac causes of dyspnea.
Key exclusion criteria (1 listed)
- Cognitive impairment severe enough to interfere with study process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Convergent Validity - Modified Borg Dyspnea Scale upright
Time frame: Through study completion, an average of 1 year.
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of Polish-language version of Modified Borg Dyspnea Scale in upright position. The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of of Polish-language version of Modified Borg Dyspnea Scale ranges between 0 and 10 with higher scores meaning a worse outcome.
Convergent Validity - Modified Borg Dyspnea Scale supine
Time frame: Through study completion, an average of 1 year.
Convergent validity will be tested by calculating the correlation of Polish language version of DALS-15 with scores of Polish-language version of Modified Borg Dyspnea Scale in supine position. The score of the Polish language version DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome. The score of of Polish-language version of Modified Borg Dyspnea Scale ranges between 0 and 10 with higher scores meaning a worse outcome.
Reliability
Time frame: Through study completion, an average of 1 year.
Reliability will be tested by calculating the correlation between Polish language version of DALS-15 scores from the 1st and 2nd administration in the randomly selected subgroup of patients. The score of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome.
Internal Consistency
Time frame: Through study completion, an average of 1 year.
Consistency between particular items of Polish language version of DALS-15 will be evaluated using Cronbach alfa test. The score of the Polish language version of DALS-15 ranges between 0 and 30 with higher scores meaning a worse outcome.
3 secondary outcomes
Convergent Validity - ALSFRS-r
Time frame: Through study completion, an average of 1 year.
Impact of fatigue on quality of life - index
Time frame: Through study completion, an average of 1 year.
Impact of fatigue on quality of life - visual analogue scale
Time frame: Through study completion, an average of 1 year.
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 19 Sep 2025.
- Background: PubMed 11464847Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.
- Individual participant dataSharing planned: Yes. After the study is completed, the scans of collected questionnaires will be available upon request sent to the e-mail: jakub.antczak@uj.edu.pl
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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.
Jakub M Antczak, MD principal investigator
Jagiellonian University
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis, run by Jakub Antczak.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jakub M Antczak, MD (+48 12 400 25 50, jakub.antczak@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Convergent Validity - Modified Borg Dyspnea Scale upright (time frame: Through study completion, an average of 1 year.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07178574, which also lists 1 linked publication.
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 19 Sep 2025.