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Could earlier breathing help in ALS? new trial aims to find out

NCT ID NCT07071935

Disease control Sponsor: University of Pennsylvania 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether starting non-invasive ventilation (a breathing machine) earlier than usual helps people with ALS. Researchers will use a prediction tool to find those at high risk of breathing problems within 6 months. 48 participants will be randomly assigned to early NIV or standard care. The goal is to gather data for a larger trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Non-invasive ventilation (NIV) device
What this could lead to
If successful, this could show that starting breathing support earlier in ALS improves quality of life and survival, leading to changes in treatment guidelines.
What could go wrong
This is a small pilot study with only 48 people, so results may not apply to everyone. Early NIV may be hard for some to tolerate, and insurance coverage remains a barrier.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 48 people

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

Started

Jun 2026

Expected to finish

May 2029

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 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: * Diagnosed with ALS using the Gold Coast Criteria within the last 6 months * Age ≥18 years * Willingness and ability to participate in study procedures * Provision of signed and dated informed consent form Exclusion Criteria: 1. Current or prior or recommended/prescribed use of NIV including: i) bi-level positive pressure ventilation, such as a respiratory assist device or home ventilator ii) Current or prior use of continuous positive airway pressure, or "CPAP" therapy 2. Forced vital capacity \<50% of predicted normal 3. Maximal inspiratory pressure \> -60 cmH2O (eg, -50 or -40 cmH2O would be excluded) 4. Chronic use of supplemental oxygen at any part of the day 5. Enrollment in hospice 6. Current tracheostomy 7. Prior history of sleep apnea where non-invasive ventilation was used or recommended 8. Thoracic, abdominal, facial or ophthalmic surgery in the prior 6 weeks 9. Coughing up blood 10. Myocardial infarction in the previous 4 weeks 11. Absolute contraindication to NIV, which includes lethargy, obtundation, facial fractures, active pneumothorax, and airway obstruction (such as a tumor) 12. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis neuromuscular disease respiratory failure

As listed by the trial registrant

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

Amyotrophic lateral sclerosis (ALS) Chronic respiratory failure Neuromuscular disease Neuromuscular disease patients Non invasive ventilation Non-invasive ventilation support Non-invasive ventilatory support Positive pressure ventilation Respiratory insufficiency Respiratory insufficiency requiring mechanical ventilation

How to take part

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

  1. The places running it

    3 sites. 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

  • Penn Comprehensive ALS Center at Pennsylvania Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Penn State Hershey ALS Clinic

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Thomas Jefferson University Weinberg ALS Center

    RECRUITING

    Philadelphi, Pennsylvania, 19107, United States

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