ALS (Amyotrophic Lateral Sclerosis)SLANCT02528071
Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis
An observational study of ALS (Amyotrophic Lateral Sclerosis), run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory muscles and can lead at short term to respiratory failure. The occurrence of respiratory failure is associated with morbidity and an increased mortality. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- What is being tested?
- Diaphragmatic endurance test
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 29 Sep 2014to 28 Oct 2020
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ALS Healthly volonteers
Who may be able to join
- Older than 18 years old and younger than 80 years old
- ALS patient seen during the diagnostic assessment
- Older than 25 years old and younger than 80 years old
- No respiratory or neurologic active pathology
Who cannot join
- Bulbar ALS (inability to perform maximal respiratory maneuvers)
- Dementia
- Respiratory failure at diagnosis (arterial carbon dioxide partial pressure (pCO2) > 45 mmHg)
- Respiratory or neurologic active pathology
- Chest wall deformation with spirometric defect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis : Impact and Prognosis. Single-center Prospective Pilot Study
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease which involves respiratory muscles and can lead at short term to respiratory failure. The occurrence of respiratory failure is associated with morbidity and an increased mortality. To date, respiratory muscle weakness is predicted from the reduction of vital capacity, maximal inspiratory force, nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these indices is low.
The investigators hypothesize that an endurance test of diaphragmatic work would be more sensitive to respiratory muscle involvement than maximal respiratory force.
Consequently, the investigators assessed diaphragmatic performance through an isocapnic hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the occurrence of respiratory failure. The investigators make the hypothesis that IHT will be altered earlier than maximal inspiratory force
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Being tested
- Diaphragmatic endurance test
- Keywords
- Amyotrophic Lateral Sclerosis, ALS, Diaphragmatic Endurance Test
- 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.
Diaphragmatic endurance testOther
This consists of hyperventilation in a flask while maintaining the constant level of Carbon Dioxide (CO2). The patient will realize hyperventilation to increasing levels of Maximum Minute Ventilation (MMV), corresponding to increasing levels of respiratory rate, until exhaustion
| Study group | Role | What they receive |
|---|---|---|
| Patients | ALS patients performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity at the onset of the disease and repeated every 3 months up to respiratory failure or death Receives: Other: Diaphragmatic endurance test | |
| Control | Healthy controls performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity. This arm will enable to establish reference values of IHT Receives: Other: Diaphragmatic endurance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time
Difference in endurance time during the IHT between healthy controls and ALS patients when diagnosis is established
Measured: Day 1
Secondary outcomes (5)
Reference values of the diaphragmatic endurance test
Reference values of the diaphragmatic endurance test in healthy controls according to age, by 10 years range.
Measured: Day 1
Reference values of phrenic nerve activity
Reference values of phrenic nerve activity in healthy controls according to age. It is measured with diaphragmatic Electromyogram by cervical electrical stimulation.
Measured: Day 1
Slope of endurance time decrease
Slope of endurance time decrease with time in ALS patients measured during IHT
Measured: At Day 1 and every 3 months of follow-up (3 years)
Amplitude of phrenic nerve
It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients
Measured: At Day 1 and every 3 months of follow-up (3 years)
Latency of phrenic nerve
It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients
Measured: At Day 1 and every 3 months of follow-up (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start29 Sep 2014
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Why it stopped: lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederic COSTES, MD PhD, Study chair, University Hospital, Clermont-FerrandIsabelle COURT-FORTUNE, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528071
- Sponsor's protocol ID
- 1308188
- Other IDs
- 2014-A00309-38
- Acronym
- SLA
- Status last verified
- Dec 2020
- First submitted
- 18 Aug 2015
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis : Impact and Prognosis. Single-center Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02528071
- Acronym / sponsor ID
- SLA / 1308188
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- Amyotrophic Lateral Sclerosis, ALS, Diaphragmatic Endurance Test
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: lack of inclusion
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 29 Sep 2014 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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 neurodegenerative disease which involves respiratory muscles and can lead at short term to respiratory failure. The occurrence of respiratory failure is associated with morbidity and an increased mortality. To date, respiratory muscle weakness is predicted from the reduction of vital capacity, maximal inspiratory force, nocturnal symptoms and hypercapnia. Even taken together, the predictive value of these indices is low.
The investigators hypothesize that an endurance test of diaphragmatic work would be more sensitive to respiratory muscle involvement than maximal respiratory force.
Consequently, the investigators assessed diaphragmatic performance through an isocapnic hyperventilation test (IHT) in patients at the onset of ALS and, then regularly up to the occurrence of respiratory failure. The investigators make the hypothesis that IHT will be altered earlier than maximal inspiratory force
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Diaphragmatic endurance testALS patients performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity at the onset of the disease and repeated every 3 months up to respiratory failure or death |
| Control | – | Other: Diaphragmatic endurance testHealthy controls performing measurements of maximal respiratory forces, diaphragmatic endurance during a diaphragmatic endurance test and phrenic nerve activity. This arm will enable to establish reference values of IHT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ALS Healthly volonteers
Key inclusion criteria (4 listed)
- Older than 18 years old and younger than 80 years old
- ALS patient seen during the diagnostic assessment
- Older than 25 years old and younger than 80 years old
- No respiratory or neurologic active pathology
Key exclusion criteria (5 listed)
- Bulbar ALS (inability to perform maximal respiratory maneuvers)
- Dementia
- Respiratory failure at diagnosis (arterial carbon dioxide partial pressure (pCO2) > 45 mmHg)
- Respiratory or neurologic active pathology
- Chest wall deformation with spirometric defect
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 |
|---|---|---|
| Diaphragmatic endurance testThis consists of hyperventilation in a flask while maintaining the constant level of Carbon Dioxide (CO2). The patient will realize hyperventilation to increasing levels of Maximum Minute Ventilation (MMV), corresponding to increasing levels of respiratory rate, until exhaustion | Other | Control, Patients |
Primary outcome
Endurance time
Time frame: Day 1
Difference in endurance time during the IHT between healthy controls and ALS patients when diagnosis is established
5 secondary outcomes
Reference values of the diaphragmatic endurance test
Time frame: Day 1
Reference values of phrenic nerve activity
Time frame: Day 1
Slope of endurance time decrease
Time frame: At Day 1 and every 3 months of follow-up (3 years)
Amplitude of phrenic nerve
Time frame: At Day 1 and every 3 months of follow-up (3 years)
Latency of phrenic nerve
Time frame: At Day 1 and every 3 months of follow-up (3 years)
Results and safety
The study was stopped early (reason given: lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
RecruitingPhase 1
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
ALS (Amyotrophic Lateral Sclerosis)
Active, not recruiting
INdependence Through Endovascular Neuroprosthetic Technology (INTENT): an Early Feasibility Study
Neurological Disorder, ALS (Amyotrophic Lateral Sclerosis)
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.
Frederic COSTES, MD PhD study chair
University Hospital, Clermont-Ferrand
Isabelle COURT-FORTUNE, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS (Amyotrophic Lateral Sclerosis), run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: lack of inclusion). Results are not available in the source record.
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?
Endurance time (time frame: Day 1). 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 5 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.