Ignite Creation Date:
2024-05-06 @ 2:29 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04332198
Status:
UNKNOWN
Last Update Posted:
2022-03-04
First Post:
2020-03-31
Brief Title:
Neurobiological and Immunological Mechanisms of Dyspnea in ALS BIOPNEA
Sponsor:
Association pour le Développement et lOrganisation de la Recherche en Pneumologie et sur le Sommeil
Organization:
Association pour le Développement et lOrganisation de la Recherche en Pneumologie et sur le Sommeil
Study Overview
Official Title:
Neurobiological and Neuro-immunological Mechanisms of Dyspnea in Amyotrophic Lateral Sclerosis
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None