Back to resultsEvaluation of the Early Use of the Pressure Relaxer in the Respiratory Impairment of Patients With Amyotrophic Lateral Sclerosis: Multicenter Randomized Controlled Study. (RELAX SLA)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
early use of intermittent positive pressure breathing
Sponsored by
About this trial
This is an interventional other trial for Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Adult patient (over 18 years old) with a diagnosis of ALS,
- - Patient who presents with an impairment of the strength of the inspiratory muscles corresponding to the degradation of the Measurement of the maximum inspiratory pressure (MIP) and/or of the inspiratory pressure during the maximum sniffle (SNIP):
- Decrease in SNIP or MIP by 10% of previous values (measured at the last follow-up visit to the center in its standard care)
- If it is his first consultation (no previous value) we will include patients if they have SNIP or MIP values <90% of the theoretical values provided by the spirometer measuring the pressures. The SNIPs and MIPs (+/-1 standard deviation) must be disturbed for inclusion of the patient.
- Patient not yet using RLX for lung recruitment or Patient using RLX only as a decluttering aid.
- Person affiliated or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
- Patient with advanced restrictive impairment = FVC<50% of theoretical values on inclusion
- Patient with proven alveolar hypoventilation or treated with non-invasive ventilation
- Patient already treated with RLX for pulmonary recruitment
- Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, minor, and person making object of a legal protection measure: guardianship or curatorship)
- Patient with a contraindication to the use of RLX (1):
- Pneumothorax
- Known intracranial hypertension
- Hemodynamic instability
- Facial or skull surgery <6 months
- Tracheoesophageal fistula
- Active bleeding
- Untreated active tuberculosis
- Rebellious Hiccup
- the history of known emphysematous or bullous pathologies
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
standard care associated with daily and early use of (IPPB) intermittent positive pressure breathing
standard care alone
Arm Description
Outcomes
Primary Outcome Measures
assess the early use of the intermittent positive pressure breathing combined with standard management slows down the deterioration of lung volumes in patients with ALS
Comparison of changes in lung volumes between the two groups based on Forced Vital Capacity (FVC), measured by spirometry during a Functional Respiratory Test (LFE)
Secondary Outcome Measures
Full Information
NCT ID
NCT05297487
First Posted
March 7, 2022
Last Updated
September 20, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT05297487
Brief Title
Evaluation of the Early Use of the Pressure Relaxer in the Respiratory Impairment of Patients With Amyotrophic Lateral Sclerosis: Multicenter Randomized Controlled Study.
Acronym
RELAX SLA
Official Title
Evaluation of the Early Use of the Pressure Relaxer in the Respiratory Impairment of Patients With Amyotrophic Lateral Sclerosis: Multicenter Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2025 (Anticipated)
Primary Completion Date
July 1, 2028 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Amyotrophic lateral sclerosis (ALS) is a rare and serious neurodegenerative disease causing degeneration of motor neurons. . It leads to a progressive paralysis of the muscles involved in voluntary motricity. In France, its incidence is 2.5/100,000 inhabitants per year.
The death of patients is mainly caused by a progressive attack of the respiratory muscles. Indeed, the thorax is no longer actively mobilized to the maximum amplitude, it will lose its flexibility. A restrictive syndrome sets in followed by alveolar hypoventilation. Bronchial congestion may be concomitant.
Management is then based on non-invasive ventilation (NIV). This step, which is difficult for patients to accept psychologically, must be delayed as much as possible. However, to date, there are no precise recommendations on preventing the appearance of this restrictive syndrome and on slowing down the deterioration of lung function in patients.
The pressure relaxer (RLX) is an instrumental aid allowing on the one hand to mobilize the thorax thanks to hyper insufflations, and on the other hand to increase the effectiveness of the cough. The use of this device in physiotherapy is part of the HAS recommendations to promote decluttering.
However, we believe that RLX in patients with ALS, through the pulmonary alveolar recruitment it induces, could be relevant at an earlier phase, for the prevention of the decline in pulmonary functions: the restrictive syndrome, bronchial congestion and alveolar hypoventilation. So ultimately, the quality of life and survival of these patients would be improved.
It is in this context that this multicenter randomized controlled study RELAX'SLA takes place in order to evaluate the effects of the early use of the pressure relaxer on the respiratory impairment of patients with ALS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard care associated with daily and early use of (IPPB) intermittent positive pressure breathing
Arm Type
Experimental
Arm Title
standard care alone
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
early use of intermittent positive pressure breathing
Intervention Description
standard care associated with daily and early use of intermittent positive pressure breathing
Primary Outcome Measure Information:
Title
assess the early use of the intermittent positive pressure breathing combined with standard management slows down the deterioration of lung volumes in patients with ALS
Description
Comparison of changes in lung volumes between the two groups based on Forced Vital Capacity (FVC), measured by spirometry during a Functional Respiratory Test (LFE)
Time Frame
EVERY 3 MONTHS DURING 24 MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient (over 18 years old) with a diagnosis of ALS,
- Patient who presents with an impairment of the strength of the inspiratory muscles corresponding to the degradation of the Measurement of the maximum inspiratory pressure (MIP) and/or of the inspiratory pressure during the maximum sniffle (SNIP):
Decrease in SNIP or MIP by 10% of previous values (measured at the last follow-up visit to the center in its standard care)
If it is his first consultation (no previous value) we will include patients if they have SNIP or MIP values <90% of the theoretical values provided by the spirometer measuring the pressures. The SNIPs and MIPs (+/-1 standard deviation) must be disturbed for inclusion of the patient.
Patient not yet using RLX for lung recruitment or Patient using RLX only as a decluttering aid.
Person affiliated or beneficiary of a social security scheme.
Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research).
Exclusion Criteria:
Patient with advanced restrictive impairment = FVC<50% of theoretical values on inclusion
Patient with proven alveolar hypoventilation or treated with non-invasive ventilation
Patient already treated with RLX for pulmonary recruitment
Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, minor, and person making object of a legal protection measure: guardianship or curatorship)
Patient with a contraindication to the use of RLX (1):
Pneumothorax
Known intracranial hypertension
Hemodynamic instability
Facial or skull surgery <6 months
Tracheoesophageal fistula
Active bleeding
Untreated active tuberculosis
Rebellious Hiccup
the history of known emphysematous or bullous pathologies
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of the Early Use of the Pressure Relaxer in the Respiratory Impairment of Patients With Amyotrophic Lateral Sclerosis: Multicenter Randomized Controlled Study.
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