Polish Version Dyspnea in Amyotrophic Lateral Sclerosis

NCT07178574 | Not Yet Recruiting

• 1 other identifier: Jagiellonian U76
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; dyspnea; DALS-15; validation; Polish-language version

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Through study completion, an average of 1 year.

Secondary Outcomes (3)

• Convergent Validity - ALSFRS-r

  Through study completion, an average of 1 year.

• Impact of fatigue on quality of life - index

  Through study completion, an average of 1 year.

• Impact of fatigue on quality of life - visual analogue scale

  Through study completion, an average of 1 year.

Study Arms (1)

ALS patients

Patients with diagnosis of ALS and with complaining of dyspnea

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

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.

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairment severe enough to interfere with study process.

Sponsors & Collaborators

• Jakub Antczak: lead

Related Publications (1)

• 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.

  PMID: 11464847 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Dyspnea

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; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jakub M Antczak, MD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub M Antczak, MD

CONTACT

+48 12 400 25 50; jakub.antczak@uj.edu.pl

Gabriela M Rusin, MD

CONTACT

+48 12 400 25 50; gabriela.rusin@uj.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study is completed for the period of ten years.
• Access Criteria: Researchers affiliated in institutions listed on clinicaltrials.gov.