Evaluating a device to improve breathing in ALS patients
Evaluation of the Effect of Respiratory Physiotherapy by Mechanical In-exsufflator on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis: A Pilot Study
This study is testing a breathing device to see if it can help people with ALS improve their cough and breathing over four weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse, Occitanie) |
| Trial ID | NCT05819931 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of a mechanical insufflator-exsufflator on the respiratory function of patients with Amyotrophic Lateral Sclerosis (ALS). It focuses on measuring peak expiratory flow on cough (PEFC) to determine the effectiveness of the treatment over a four-week period. Patients will undergo three weekly sessions for two weeks, followed by daily sessions for an additional two weeks, all while receiving physiotherapy support. The study aims to provide insights into how this intervention can enhance respiratory function in ALS patients with ineffective cough.
Who should consider this trial
Good fit: Ideal candidates are ALS patients with a peak expiratory flow between 160 and 255 L/min who have not received mechanical insufflator-exsufflator treatment in the past year.
Not a fit: Patients with psychiatric or cognitive disorders, contraindications to using the device, or insufficient French language skills may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve respiratory function and quality of life for ALS patients.
How similar studies have performed: While the approach of using mechanical insufflator-exsufflator devices is established, this specific evaluation in ALS patients is novel and may provide new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 Exclusion during the study : * 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
Where this trial is running
Toulouse, Occitanie
- SLA Center - Purpan University Hospital Toulouse, FRANCE — Toulouse, Occitanie, France (Recruiting)
Study contacts
- Principal investigator: Thierry Lagarde — University Hospital, Toulouse
- Study coordinator: Thierry LAGARDE, PT
- Email: lagarde.t@chu-toulouse.fr
- Phone: +33561775570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.