NCT05913882 Combined Respiratory Training in Persons With ALS
| NCT ID | NCT05913882 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nova Southeastern University |
| Condition | ALS |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2023-08-22 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2023-08-22 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this interventional trial is to learn about lung volume recruitment (LVR) and expiratory muscle strength training (EMST) in a total of up to 39 patients diagnosed with ALS. The following aims will be addressed: 1. Determine the impact of combined LVR and EMST on cough strength and respiratory function in individuals with ALS. 2. Determine the impact of combined LVR and EMST on patient-reported dyspnea and bulbar impairment. 3. Describe the effect of combined LVR and EMST on patient- and caregiver reported burden and quality of life.
Eligibility Criteria
Inclusion Criteria: 1. A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria. 2. Disease duration from symptom onset of ≤ 2 years, 3. Lung volume recruitment and expiratory muscle strength training naïve, 4. Reduced peak cough flow (% predicted for age and gender). Exclusion Criteria: 1. History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment. 2. Use of prescription cough assist or non-invasive volume ventilation devices. 3. Enrollment in another research investigation that might impact cough or respiratory function. 4. Diagnosis of frontotemporal dementia or advanced cognitive impairment. 5. Tracheostomy placement/Use of invasive mechanical ventilation. 6. Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease).
Contact & Investigator
Magalie Thomas, MBA
STUDY CHAIR
Nova Southeastern University
Frequently Asked Questions
Who can join the NCT05913882 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying ALS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05913882 currently recruiting?
Yes, NCT05913882 is actively recruiting participants. Contact the research team at Lgray1@nova.edu for enrollment information.
Where is the NCT05913882 trial being conducted?
This trial is being conducted at Fort Lauderdale, United States.
Who is sponsoring the NCT05913882 clinical trial?
NCT05913882 is sponsored by Nova Southeastern University. The principal investigator is Magalie Thomas, MBA at Nova Southeastern University. The trial plans to enroll 34 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.