Breathing and swallowing training for people with ALS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial aims to evaluate the effects of combined lung volume recruitment (LVR) and expiratory muscle strength training (EMST) on respiratory function and quality of life in patients diagnosed with ALS. The study will involve up to 39 participants who will undergo a series of assessments and telehealth therapy sessions to monitor cough strength, dyspnea, and overall well-being. Participants will serve as their own controls, allowing for a more accurate assessment of the treatment's impact over time. The trial includes both in-person evaluations and remote training sessions to ensure adherence and effectiveness.

Why it matters

Who can join: the full rules

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).

Where it's running

• Nova Southeastern University
  Fort Lauderdale, Florida, United States Recruiting

Study contacts

• Study coordinator: Lauren Tabor Gray, PhD
• Email: Lgray1@nova.edu
• Phone: 954-262-8963

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.