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New breathing training aims to boost cough strength in ALS patients

NCT ID NCT05913882

Symptom relief Sponsor: Nova Southeastern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests two types of breathing exercises together in people with ALS. The goal is to see if these exercises can improve cough strength and breathing, and reduce shortness of breath. Up to 34 people with ALS will participate, and the study also looks at how the exercises affect quality of life for both patients and caregivers.

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

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

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 to 90 years

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. A diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria. 2. Disease duration from symptom onset of ≤ 2 years, 3. Lung volume recruitment and expiratory muscle strength training naïve, 4. Reduced peak cough flow (% predicted for age and gender). Exclusion Criteria: 1. History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment. 2. Use of prescription cough assist or non-invasive volume ventilation devices. 3. Enrollment in another research investigation that might impact cough or respiratory function. 4. Diagnosis of frontotemporal dementia or advanced cognitive impairment. 5. Tracheostomy placement/Use of invasive mechanical ventilation. 6. Contraindications for respiratory training (i.e., history of pneumothorax, severe chronic obstructive pulmonary disease).

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis Deglutition Disorders Motor Activity Respiratory Aspiration respiratory failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALS Dysphagia Respiratory insufficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nova Southeastern University

    RECRUITING

    Fort Lauderdale, Florida, 33314, United States

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