Breathing With Amyotrophic Lateral Sclerosis

NCT05819931 | Recruiting

• 1 other identifier: RC31/22/0411
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the effect of mechanical insufflator-exsufflator on the respiratory functions of Amyotrophic Lateral Sclerosis (ALS) patients evaluated via peak expiratory flow on cough (PEFC) measurements. The evolution of their PEFC is monitored to see if the curative management can have a positive impact on the latter.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Mechanical In-Exsufflator; Physiotherapy; Cough; peak expiratory flow on cough

Outcome Measures

Primary Outcomes (1)

• cough peak expiratory flow evolution

  evolution of respiratory function by peak expiratory flow on cough (PEFC) after 4 weeks of treatment with Mechanical In-Exsufflator (3 weekly sessions for two weeks then one daily session for 2 weeks) in ALS patients presenting with a poorly effective cough (Cough Peak Expiratory Flow between 160 and 255) and having an indication of punctual MIE. Ratio between the PEFC 4 weeks post treatment initiation and PEFC at baseline can show decrease in respiratory function if \<1 ; increase in respiratory functions if \>1 and a conservation of respiratory function if = 1. A PEFC remaining within 10% of its initial value (rounded to the nearest ten) is considered unmodified

  4 weeks post treatment initiation

Study Arms (1)

Mechanical In-Exsufflator treatment

EXPERIMENTAL

Device: Mechanical In-Exsufflator treatment

Interventions

Mechanical In-Exsufflator treatment DEVICE

The Mechanical In-Exsufflator (MIE) is a device that alternately inhales and exhales air and amplifies the respiratory cycles in flow and pressure. 15 breathing cycles (about 3 minutes) are recommended each day. Patients will practice the MIE daily independently and/or carried out by his physiotherapist (PT) during PT sessions. The MIE is prescribed by the neurologist or pulmonologist and is covered by social security in France. It is gifted by an external service provider. The Peak-Flow Cough is considered as the standardized score retaining the best of 3 consecutive measurements by Peak-Flow, a small portable device for personal use, which measures the maximum expiratory flow reached by the patient at the moment when the breath is most powerful. The patient is his own control. At baseline, the patient will be treated as usual. He will be asked to read the Peak-Flow Cough measures. The PT will also perform the Peak flow measurement at each patient visit.

Mechanical In-Exsufflator treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed ALS categorized as probable or certain according to the revised Awaji-Shima criteria \[27\].
• ALS of spinal, bulbar or respiratory forms
• Peak Flow measure between 160 and 255 L/min (recommendation of MIE in case of congestion, with the possibility of daily sessions)
• Patient who has not benefited from treatment by MIE in the past year (less than 10 sessions in total)
• Patient able to use the MIE and perform the collection, or having a caregiver able to help
• Patient receiving physiotherapist treatment greater than or equal to twice a week

You may not qualify if:

• Psychiatric (DSM-5) or cognitive disorders incompatible with participation in the study
• Contraindication to the use of an MIE (pneumothorax for example)
• Insufficient level in French for understanding the study and completing the questionnaires
• Current or past participation in another innovative research or care program relating to respiratory functions
• Emergency situation for which the MIE must be set up within less than a week
• Appearance of a serious contraindication to the practice of MIE during the study (for example rib fracture during a fall)
• Patient's physiotherapist refusing to do the study

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

SLA Center - Purpan University Hospital Toulouse, FRANCE

Toulouse, Occitanie, 31000, France

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Cough

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thierry Lagarde

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry LAGARDE, PT

CONTACT

+33561775570; lagarde.t@chu-toulouse.fr

Floriane LLORENS

CONTACT

llorens.fl@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: before-after comparison of the treatment

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: August 29, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

FR (1)