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Clinical Trials in Germany / NCT05903001
Recruiting Observational

Diaphragmatic Function as a Biomarker

NCT05903001 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2023-07-01
Last updated
2026-01-28

Condition(s) studied

Dyspnea; AsthmaticCOPDFibrosisPulmonary HypertensionAsthmaDyspnea

Investigational drug(s) / intervention(s)

Diaphragm UltrasoundIntercostal Muscle UltrasoundBorg scaleMRC Breathlessness ScaleRespiratory QuestionaireGINA classification of AsthmaMeasurement of respiratory mouth pressureSNIP6-minute walking distance60 seconds sit-to-stand testElectromyographyLung FunctionCAT-QuestionnaireEuropean Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group

Diaphragm Ultrasound: Ultrasound of the Diaphragm at the end of inspiration and expiration

Intercostal Muscle Ultrasound: Ultrasound of the Intercostal Muscles at the end of inspiration and expiration

Borg scale: Questionnaire for Perceived Exertion (Borg Rating of Perceived Exertion Scale)

MRC Breathlessness Scale: The MRC Dyspnoea Scale allows the patients to indicate the extent to which their breathlessness affects their mobility.

Respiratory Questionaire: Specialized respiratory questionnaire with different domains (Emotional Domain, Dyspnea Domain, Mastery Domain, Fatigue Domain)

GINA classification of Asthma: Patients are classified according to the GINA classification of Asthma.

Measurement of respiratory mouth pressure: Inspiratory and expiratory Measurement of respiratory mouth pressure

SNIP: Measurement of Sniff Nasal Inspiratory Pressure

6-minute walking distance: The maximum walking distance achieved in 6 minutes

60 seconds sit-to-stand test: number of repetitions achieved in sitting down and standing up in 60 seconds

Electromyography: electromyography of the muscles of respiration via superficial electrodes

Lung Function: Measurement of lung function via body plethysmography

CAT-Questionnaire: COPD Assessment Test (CAT)

European Society of Cardiology (ESC)/ European Respiratory Society (ERS) risk group: Patients with pulmonary hypertension are classified according to the ESC/ERS risk group.

Study summary

Dyspnea is among the most common symptoms in patients with respiratory diseases such as Asthma, chronic obstructive pulmonary disease (COPD), Fibrosis, and Pulmonary Hypertension. However, the pathophysiology and underlying mechanisms of dyspnea in patients with respiratory diseases are still poorly understood. Diaphragm dysfunction might be highly prevalent in patients with dyspnea and respiratory diseases. The association of diaphragm function and potential prognostic significance in patients with respiratory diseases has not yet been investigated.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * patient has one of the following lung diseases: COPD, bronchial asthma, pulmonary fibrosis, pulmonary hypertension * is 18 years or older * is mentally and physically able to understand the study and to follow instructions * are legally competent * signed declaration of consent Exclusion Criteria: * BMI \> 35 * current or treatments or diseases in the past which could influence the evaluation of the study * Expected lack of willingness to actively participate in study-related measures * alcohol or drug abuse * disc herniation/prolapse * epilepsy * wheelchair bound * in custody due to an official or court order * in a dependent relationship or employment relationship with investigating physician or one of their deputy * emergency inpatient hospital stay within 4 weeks before study-specific examinations

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
RWTH Aachen University Hospital Aachen North Rhine-Westphalia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05903001 on ClinicalTrials.gov ↗ ← All trials in Germany