Early Non-Invasive Ventilation in ALS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial explores early initiation of non-invasive ventilation (NIV) in adults diagnosed with ALS who meet specific respiratory criteria. The study aims to collect feasibility data, estimate effect sizes, and identify personal factors that influence NIV use, in preparation for a larger Phase III trial. Participants must have ALS diagnosed within the last six months, be 18 or older, and consent to procedures. Exclusions include prior NIV use, significant respiratory impairment, recent surgery, certain cardiac or systemic conditions, and other safety considerations. The trial is led by the University of Pennsylvania with collaboration from the U.S. Department of Defense and several ALS clinics in Pennsylvania.

Why it matters

Who can join: the full rules

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

Where it's running

• Penn State Hershey ALS Clinic
  Hershey, Pennsylvania, United States Recruiting
• Penn Comprehensive ALS Center at Pennsylvania Hospital
  Philadelphia, Pennsylvania, United States Recruiting
• Thomas Jefferson University Weinberg ALS Center
  Philadelphi, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Jason T Ackrivo, MD, MSCE — Perelman School of Medicine at the University of Pennsylvania
• Study coordinator: Jason T Ackrivo, MD, MSCE
• Email: jason.ackrivo@pennmedicine.upenn.edu
• Phone: 215-829-3053

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Turkish version of the S3-NIV questionnaire: testing its reliability for home NIV patients

  We’re testing whether the Turkish S3-NIV questionnaire reliably measures how well patients on home non-invasive ventilation can manage daily use and comfort.

  Recruiting Istanbul Saglik Bilimleri University · Istanbul · NCT07610122

• Improving home ventilation for chronic respiratory failure patients

  This study is testing a new way to monitor patients with chronic respiratory failure who use home ventilation to see if it improves their breathing comfort and effectiveness.

  Recruiting University Medical Center Groningen · Groningen · NCT05756387

• Early detection of respiratory impairment in ALS using breathing, MRI, and blood markers

  This study tests whether breathing patterns, MRI changes in the brainstem and spinal cord, and blood markers can reveal early ALS signs, especially in people with genetic risk or early symptoms.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07844590

• Dynamic, non-invasive monitoring of breathing effort to guide weaning from mechanical ventilation

  This observational study tests whether daily non-invasive measurements of a patient’s breathing effort can predict when it’s safe to take them off invasive ventilation.

  Recruiting Fundació d'investigació Sanitària de les Illes Balears · Palma de Mallorca, Balearic Islands · NCT07839949

• Bedside Spirometry to see if tidal volume matches ideal body weight in non-intubated ARDS

  This pilot study tests whether tidal volume measured at bedside with high-flow oxygen and after NIV settings can help classify ARDS patients who are not intubated.

  Recruiting Centre Hospitalier Departemental Vendee · La Roche-sur-Yon and 1 other locations · NCT07750717

• Early breathing therapy just one hour after CABG extubation

  This trial tests whether starting respiratory physiotherapy one hour after extubation improves recovery for adults after elective CABG compared with starting on the first postoperative day.

  Recruiting Alma Mater Europaea - Slovenia · Zagreb · NCT07730034

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.