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Can a daily breathing exercise slow ALS lung decline?

NCT ID NCT06119087

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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