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

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: ALS (Amyotrophic Lateral Sclerosis)

Treatments: Other: Diaphragmatic endurance test

Study type: Observational

Funder types: Other

Identifiers

NCT02528071

2014-A00309-38 (Other Identifier)

1308188

Details and patient eligibility

About

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

Enrollment: 136 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

136 participants in 2 patient groups

Patients

Description:

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

Treatment:

Other: Diaphragmatic endurance test

Control

Description:

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

Treatment:

Other: Diaphragmatic endurance test