Neurobiological and Immunological Mechanisms of Dyspnea in ALS (BIOPNEA)

NCT04332198 | Unknown

• 1 other identifier: 2019_A02882_55
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shortness of Breath; Dyspnea; Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• the cytokines and endorphins rates variation after initiation of NIV in ALS patients

  measure cytokines and endorphins blood levels before and after NIV

  30 minutes

Study Arms (1)

ALS patients

EXPERIMENTAL

Other: biological test

Interventions

biological test OTHER

dyspnea evaluation, ventilatory evaluation and biological test before and after non invasive ventilation

Also known as: questionnaire

ALS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients with chronic respiratory failure with diaphragmatic dysfunction linked to amyotrophic lateral sclerosis and requiring long-term NIV

You may not qualify if:

• Other respiratory disease (COPD, asthma, obstructive sleep apnea)
• Alcohol or psychotropic drug the lasts 24 hours
• Cognitive impairment
• Smoking \> 10 PA
• Exacerbation or infection 6 weeks earlier
• Endstage of illness
• Chronic or acute pain (VAS \> 3)

Sponsors & Collaborators

• Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil: lead

MeSH Terms

Conditions

Dyspnea; Amyotrophic Lateral Sclerosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: July 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 4, 2022

Record last verified: 2022-02