An interventional study of Effective noninvasive ventilation and Sham noninvasive ventilation in Chronic Obstructive Pulmonary Disease Severe and Dyspnea, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-01-29.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science
Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality.
COPD is a chronic inflammatory disease of the bronchi, affecting 8% of the French population (more than 3 million people). By 2030, it will be the third leading cause of death worldwide. Effective management of dyspnea in these patients is a priority.
In patients with severe COPD, physical exertion increases the workload of breathing, leading to dyspnea. At the same time, the respiratory muscles and fatty cells release cytokines, myokines and adipokines - a group of proteins involved in the inflammatory response. In addition, 15% of COPD patients suffer from sarcopenia (loss of muscle mass and strength) which increases respiratory effort and dyspnea.
Our research project aims to study the effect of dyspnea relief in COPD patients on cytokine, myokine and adipokine levels, taking into account the presence of sarcopenia. Indeed, it is possible to alleviate the workload of the respiratory muscles during exercise by means of respiratory assistance.
The ultimate goal is a better understanding of dyspnea mechanisms, to enable the development of cytokine-targeted therapies and improve quality of life and survival in these patients.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 26 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Alleviate dyspnea (lower Borg Score by 2 points)
Device: Effective noninvasive ventilation
Device: Sham noninvasive ventilation
Noninvasive ventilation set to alleviate dyspnea Inspiratory aid set according to a preliminary test (aiming for a diminution of 2 points in Borg score)
Noninvasive ventilation set with an insufficient inspiratory aid to alleviate dyspnea
Variation in exercise-induced release of cytokines IL-1, IL-6, IL-8, IL-10 and TNF-alpha plasma concentrations (pg/mL) between the two ventilatory conditions (sham and effective)
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Variation in exercise-induced release of adipokines adiponectin and leptin concentrations (pg/mL) between the two ventilatory conditions (sham and effective)
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between dyspnea descriptors (Borg scale score, Multidimensional Dyspnea Profil score) and cytokines, adipokines and myokines plasma concentrations (pg/mL)
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between muscle mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between fat mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Plan to share: No
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University Hospital, Clermont-Ferrand