Amyotrophic Lateral SclerosisRELAX SLANCT05297487
Evaluation of the Early Use of the Pressure Relaxer in the Respiratory Impairment of Patients With Amyotrophic Lateral Sclerosis: Multicenter Randomized Controlled Study.
A study testing early use of intermittent positive pressure breathing in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de la Réunion.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- early use of intermittent positive pressure breathing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
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.
Read more
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.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- early use of intermittent positive pressure breathing
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early use of intermittent positive pressure breathingDevice
standard care associated with daily and early use of intermittent positive pressure breathing
| Study group | Role | What they receive |
|---|---|---|
| standard care associated with daily and early use of (IPPB) intermittent positive pressure breathing | Experimental | Not described Receives: Device: early use of intermittent positive pressure breathing |
| standard care alone | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: EVERY 3 MONTHS DURING 24 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Why it stopped: lack of human ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297487
- Sponsor's protocol ID
- 2021/CHU/08
- Acronym
- RELAX SLA
- Status last verified
- Sep 2026
- First submitted
- 7 Mar 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05297487
- Acronym / sponsor ID
- RELAX SLA / 2021/CHU/08
- Conditions
- Amyotrophic Lateral Sclerosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of human ressources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard care associated with daily and early use of (IPPB) intermittent positive pressure breathing | Experimental | Device: early use of intermittent positive pressure breathing |
| standard care alone | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early use of intermittent positive pressure breathingstandard care associated with daily and early use of intermittent positive pressure breathing | Device | standard care associated with daily and early use of (IPPB) intermittent positive pressure breathing |
Primary outcome
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
Time frame: EVERY 3 MONTHS DURING 24 MONTHS
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing early use of intermittent positive pressure breathing in people with Amyotrophic Lateral Sclerosis, run by Centre Hospitalier Universitaire de la Réunion.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: EVERY 3 MONTHS DURING 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.