An interventional study of biological test in Shortness of Breath, Dyspnea and Amyotrophic Lateral Sclerosis, sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-04.
Sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil · Not applicable, Interventional, and Other
Among 10 studies in Dyspnea by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil — 1 open to participants now, 1 under way, none of them phase 3. Dyspnea · Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil.
Among the 10 studies in Dyspnea by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil, this one is the only one that started in 2023, is one of 6 with no phase, and was the 7th registered.
894 studies on the registry are indexed under Dyspnea; 189 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 587 interventional studies indexed under Dyspnea.
Browse Dyspnea studies →1 of the 10 studies in Dyspnea by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil is open now, in 1 country. Each count lists the studies.
Of the 124 Dyspnea studies recruiting now, 69 (56%) set no upper age limit and 40 (32%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 1 started in 2023.
Median enrollment 33 across the 6 interventional studies, 20 across the 4 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Dyspnea by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil, from their registry updates:
Nothing recorded among them since 2026-09-25.
Dyspnea; subjective experience of respiratory discomfort; which produces negative emotional experience, is the most common symptom of patients afflicted with chronic respiratory failure and its treatments are limited. Amyotrophic Lateral Sclerosis (ALS) related - dyspnea, due to diaphragmatic dysfunction, is similar to dyspnea during mechanical inspiratory load (activation of the supplementary motor area, SMA). The perception of pain and dyspnea is processed in similar brain areas (insula, dorsal anterior cingulate cortex, amygdala and medial thalamus) and in ALS; relieving dyspnea by noninvasive ventilation (NIV) is associated with decreased pain thresholds. Otherwise, it is reported systemic elevations of pro-inflammatory cytokines in chronic pain patients, correlating with intensity of pain, and during respiratory load in healthy volunteers.
The objectives are to evaluate the cytokines and endorphins rates variations after initiation of NIV in ALS patients, and to correlate cytokines and endorphins rates with the intensity of the affective component and the intensity of the sensory component of dyspnea.
The investigators will perform a prospective, experimental study, including 30 ALS patients. Dyspnea, ventilatory and cardiac settings, electromyographic recording of the scalene muscle and biological assays (ACTH, endorphin, Neuropeptide P, BDNF, IL1, IL6, IL8, IL10, TNF), will be measured during spontaneous breathing and during NIV at different times after initiation.
The investigators expect a reduction of immunological and neurobiological markers after relieving dyspnea by NIV. This work could lead to the development of new treatments for dyspnea.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: biological test
dyspnea evaluation, ventilatory evaluation and biological test before and after non invasive ventilation
Also known as: questionnaire
the cytokines and endorphins rates variation after initiation of NIV in ALS patients
measure cytokines and endorphins blood levels before and after NIV
Time frame: 30 minutes
No study locations are listed for this record.
Start is estimated for Jul 2023; primary completion for Oct 2024, 15 months later.
Of 266 non-industry interventional studies with no phase under Dyspnea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 15 months is above that.
Counting every sponsor, half of 282 studies reached it within 13 months; a quarter within 6 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil