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Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Please note: All trial information reflects the latest data available from the sponsor on ClinicalTrials.gov and other public databases. However, these sources may occasionally be outdated or inaccurate. For the most current information, we recommend contacting the trial sponsor or sites directly.

Overview

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Approved by FDA
Approved outside USA
Is a supplement

Details

Enrollment Criteria

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A tele-health treatment study for individuals with early stage ALS with the aim to improve communication, cough response, and respiratory strength. All participants complete a respiratory strength training program using an Expiratory Muscle Strength Training (EMST 150) device from the comfort of their homes for 6 weeks.

The investigators are looking for people with early stage ALS to participate in a completely tele-health (no in-person visits required) treatment study examining the effects of an Expiratory Muscle Strength Training device (EMST-150) on communication, cough, and respiratory strength. Participants will be required to attend 2 virtual baseline assessment sessions followed by 12 additional virtual training sessions (2 per week for 6 weeks). Participants should plan to be actively enrolled in the study for ~10 weeks (3 weeks of baseline monitoring followed by 6 weeks of training). Participants will also be required to fill out a series of questionnaires assessing the EMST's effectiveness via tele-health.

Inclusion Criteria:
- Diagnosis of ALS
- Within the early stages of disease progression (i.e., able to talk, breathe, and eat
independently)
- Speaker of English
- Have a family member/caregiver willing to assist as needed
- Have access to an electronic device and internet for tele-health
Exclusion Criteria:
- A history of neurological disease (besides ALS)
- A history of asthma or respiratory problems (e.g., COPD, emphysema)
- A history of head, neck, or chest surgery (except mastectomy)
- A history of smoking within the last 5 years
- Reliance on mechanical ventilation (including CPAP)

Locations
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Thank You to Our Sponsors
Mitsubishi Tanabe Pharma