Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Jessica E Huber, Ph.D. Purdue University

Clinicaltrials.gov ID (11 digit #):

NCT05003167

Neals Affiliated?

No

Coordinating Center Contact Information

Purdue University
Brianna Kiefer, MS / .(JavaScript must be enabled to view this email address) / 209-607-4979
.(JavaScript must be enabled to view this email address) West Lafayette, Indiana 47906 United States

Full Study Summary:

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.

Study Sponsor:

Purdue University

Participant Duration:

~10 weeks (3 weeks of baseline monitoring followed by 6 weeks of training)

Estimated Enrollment:

30

Estimated Study Start Date:

01/01/2021

Estimated Study Completion Date:

05/01/2022

Posting Last Modified Date:

11/02/2021

Date Study Added to alsconsortium.org:

11/02/2021
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    40

    Maximum Age:

    70

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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)

  • Site Contact Information

    Purdue University
    Brianna R Kiefer, MS / .(JavaScript must be enabled to view this email address) / 765-494-3796
    Sandy Snyder, MS / .(JavaScript must be enabled to view this email address) / 765-494-3796
    West Lafayette, Indiana 47906
    United States