Can a daily breathing exercise slow ALS lung decline?
NCT ID NCT06119087
First seen Jun 24, 2026 · Last updated Aug 13, 2026 · Updated 3 times
Summary
This study tests whether using a mechanical insufflation device (BiWaze Cough) twice daily for 6 months can slow the decline in cough strength in 20 people with early ALS. Participants will use a facemask or mouthpiece to help inflate their lungs fully before coughing. Researchers will compare their peak cough flow to a similar group not using the device.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Mechanical insufflation using the BiWaze Cough device
- What this could lead to
- If it works, this could point toward a simple daily exercise to help people with early ALS maintain stronger coughs and better breathing for longer.
- What could go wrong
- This is a very small, early study with only 20 participants and no control group, so results may not apply to everyone. The device may be uncomfortable or hard to use daily.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
23 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
-
Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Age ≥18 years. 4. Diagnosed with amyotrophic lateral sclerosis using the Gold Coast Criteria. 5. Have an able and willing caregiver to assist with mechanical insufflation on a daily basis. 6. Willingness and ability to participate in study procedures. Exclusion Criteria: 1. Age \<18 years old. 2. Inability to perform a cough peak flow or spirometry manuever 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. 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. Active enrollment in hospice. 6. Current tracheostomy. 7. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician. 8. Absence of an able and willing caregiver to assist with MI twice daily as specified in the protocol. 9. Pregnancy 10. Medical history of any of the following: 1. Recent hemoptysis 2. Recent barotrauma 3. History of emphysema of any kind (including bullous emphysema) 4. History of or known susceptibility to pneumothorax 5. History of or known susceptibility to pneumomediastinum 6. Chronic obstructive pulmonary disease 7. Uncontrolled asthma (defined as recent exacerbation requiring corticosteroids in the previous 30 days) 8. Symptomatic cardiomyopathy (heart failure) with left ventricular ejection fraction less than 50% 9. History of right heart failure or pulmonary hypertension 11. Current smoker or tobacco use within the last 30 days.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Airway clearance impairment are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Can a NAD-Boosting supplement slow ALS? extension trial tests nicotinamide riboside and pterostilbene
- Breathing support in ALS: what it means for patients and families
- Virtual reality and robots put to the test in neuromuscular rehab
- Breathing device tested to slow lung decline in ALS
- Can hospital codes reliably track home ventilation in ALS?