Prognostic Value of a Diaphragmatic Endurance Test in Patients With Amyotrophic Lateral Sclerosis (SLA)

December 31, 2020 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with ALS Healthly volonteers

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Diaphragmatic endurance test
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
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
Other: Diaphragmatic endurance test
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
Difference in endurance time during the IHT between healthy controls and ALS patients when diagnosis is established
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reference values of the diaphragmatic endurance test
Time Frame: Day 1
Reference values of the diaphragmatic endurance test in healthy controls according to age, by 10 years range.
Day 1
Reference values of phrenic nerve activity
Time Frame: Day 1
Reference values of phrenic nerve activity in healthy controls according to age. It is measured with diaphragmatic Electromyogram by cervical electrical stimulation.
Day 1
Slope of endurance time decrease
Time Frame: At Day 1 and every 3 months of follow-up (3 years)
Slope of endurance time decrease with time in ALS patients measured during IHT
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)
It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients
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)
It is the relationship between phrenic nerve activity and diaphragmatic endurance in ALS patients
At Day 1 and every 3 months of follow-up (3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Study Chair: Frederic COSTES, MD PhD, CHU de Clermont-Ferrand
  • Principal Investigator: Isabelle COURT-FORTUNE, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2014

Primary Completion (Actual)

October 28, 2020

Study Completion (Actual)

October 28, 2020

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

December 31, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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