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Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study

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Conditions

Amyotrophic Lateral SclerosisChronic Respiratory FailureAirway Clearance ImpairmentNeuromuscular Diseasesneuromuscular weaknessmechanical insufflation-exsufflationpeak cough flow

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn how doing mechanical insufflation (MI) using a mechanical insufflator-exsufflator (MI-E) device affects breathing in early amyotrophic lateral sclerosis (ALS). This will be a single-center, single-arm study of MI in 20 patients with ALS at Penn. Based on prior research, we believe that 6-months of MI may slow decline in cough strength, measured as peak cough flow (PCF). Participants will perform MI using a device designed for mechanical insufflation-exsufflation (MI-E) known as the BiWaze Cough system. The BiWaze Cough is used for mucus clearance . It is connected to tubing and mouthpiece (or mask). The device will use programmed pressure and timing settings. An insufflation includes inflating the lungs for a maximal size inhalation before exhaling. The daily routine for the device includes 5 sets of 5 insufflations twice daily. Researchers will compare how use of MI in early ALS affects peak cough flow compared to 20 subjects who did not use MI in early ALS.

Official Title

Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study

Quick Facts

Study Start:2024-09-12
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06119087

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form.
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. 3. Age ≥18 years.
  4. 4. Diagnosed with amyotrophic lateral sclerosis using the Gold Coast Criteria.
  5. 5. Have an able and willing caregiver to assist with mechanical insufflation on a daily basis.
  6. 6. Willingness and ability to participate in study procedures.
  1. 1. Age \<18 years old.
  2. 2. Inability to perform a cough peak flow or spirometry manuever
  3. 3. Current use of non-invasive ventilation (NIV), bi-level positive pressure ventilation, or "Bi-PAP" or physician prescribing NIV on day of potential enrollment.
  4. 4. Current use of MI-E (also known as a "cough assist device") for airway clearance. Please note that patients can start use of a MI-E device subsequent to enrollment while currently being followed for the study.
  5. 5. Active enrollment in hospice.
  6. 6. Current tracheostomy.
  7. 7. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician.
  8. 8. Absence of an able and willing caregiver to assist with MI twice daily as specified in the protocol.
  9. 9. Pregnancy
  10. 10. Medical history of any of the following:
  11. 1. Recent hemoptysis
  12. 2. Recent barotrauma
  13. 3. History of emphysema of any kind (including bullous emphysema)
  14. 4. History of or known susceptibility to pneumothorax
  15. 5. History of or known susceptibility to pneumomediastinum
  16. 6. Chronic obstructive pulmonary disease
  17. 7. Uncontrolled asthma (defined as recent exacerbation requiring corticosteroids in the previous 30 days)
  18. 8. Symptomatic cardiomyopathy (heart failure) with left ventricular ejection fraction less than 50%
  19. 9. History of right heart failure or pulmonary hypertension
  20. 11. Current smoker or tobacco use within the last 30 days.

Contacts and Locations

Study Contact

Jason Ackrivo, MD
CONTACT
2156623202
jason.ackrivo@pennmedicine.upenn.edu

Principal Investigator

Jason Ackrivo, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Jason Ackrivo, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-12
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-09-12
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • amyotrophic lateral sclerosis
  • chronic respiratory failure
  • neuromuscular weakness
  • mechanical insufflation-exsufflation
  • peak cough flow

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis
  • Chronic Respiratory Failure
  • Airway Clearance Impairment
  • Neuromuscular Diseases