- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02528071
Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis (SLA)
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Saint-etienne, France, 42000
- CHU de Saint-Etienne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for Patients :
- Older than 18 years old and younger than 80 years old
- ALS patient seen during the diagnostic assessment
Inclusion Criteria for control group :
- Older than 25 years old and younger than 80 years old
- No respiratory or neurologic active pathology
Exclusion Criteria for Patients :
- 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
Exclusion Criteria for control group :
- Chest wall deformation with spirometric defect
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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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
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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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endurance time
Time Frame: Day 1
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Difference in endurance time during the IHT between healthy controls and ALS patients when diagnosis is established
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reference values of the diaphragmatic endurance test
Time Frame: Day 1
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Reference values of the diaphragmatic endurance test in healthy controls according to age, by 10 years range.
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Day 1
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Reference values of phrenic nerve activity
Time Frame: Day 1
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Reference values of phrenic nerve activity in healthy controls according to age.
It is measured with diaphragmatic Electromyogram by cervical electrical stimulation.
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Day 1
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Slope of endurance time decrease
Time Frame: At Day 1 and every 3 months of follow-up (3 years)
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Slope of endurance time decrease with time in ALS patients measured during IHT
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At Day 1 and every 3 months of follow-up (3 years)
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Amplitude of phrenic nerve
Time Frame: At Day 1 and every 3 months of follow-up (3 years)
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It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients
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At Day 1 and every 3 months of follow-up (3 years)
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Latency of phrenic nerve
Time Frame: At Day 1 and every 3 months of follow-up (3 years)
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It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients
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At Day 1 and every 3 months of follow-up (3 years)
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Collaborators and Investigators
Investigators
- Study Chair: Frederic COSTES, MD PhD, CHU de Clermont-Ferrand
- Principal Investigator: Isabelle COURT-FORTUNE, MD, CHU de Saint-Etienne
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1308188
- 2014-A00309-38 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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