Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 to 80

Evaluating a new breathing device for patients with neuromuscular diseases

Official title: A Proof-on-concept Study to Investigate the Potential Use of Volume-targeted Ventilation in Patients With Slowly Progressive Neuromuscular Disease

Run by Guy's and St Thomas' NHS Foundation Trust · NCT06339580 · Data updated 2026-11-12

This study is testing a new breathing device that adjusts to patients' needs to see if it helps people with neuromuscular diseases breathe better than their current equipment.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment30 (estimated)
SponsorGuy's and St Thomas' NHS Foundation Trust
Academic / other
Locations2 sites (London, London and 1 other locations)
StatusRecruiting
StartedApril 9, 2024
Main results expectedSeptember 30, 2026
Study endsSeptember 30, 2026
Registry record updatedJune 8, 2026
Trial IDNCT06339580 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 to 80 with slowly progressive neuromuscular diseases who are stable on fixed bi-level ventilation.

Probably not a fit

Patients with rapidly progressive neuromuscular diseases or those experiencing decompensated respiratory failure may not benefit from this study.

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

What this trial studies

This study assesses the safety and efficacy of volume-targeted non-invasive ventilation (VT-NIV) in patients with neuromuscular diseases who require breathing support. Participants will be admitted for two nights, during which their carbon dioxide control will be evaluated using their current fixed non-invasive ventilation device. On the second night, they will switch to the VT-NIV mode, which adjusts pressures based on patient needs to deliver a target volume of air. The goal is to gather data that will inform a future randomized controlled trial comparing VT-NIV with traditional fixed ventilation methods.

Why it matters

Potential benefit: If successful, this approach could lead to improved respiratory outcomes and quality of life for patients with neuromuscular diseases.

How similar studies have gone: There have been a few studies suggesting that auto-titrating ventilation may improve carbon dioxide control, but further investigation is needed to confirm these findings.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Slowly progressive neuromuscular disease
* Established on fixed bi-level ventilation
* Documented clinical respiratory stability by supervising clinician (no hospitalizations, respiratory infections or change to ventilator settings in preceding 6 weeks)

Exclusion Criteria:

* Rapidly progressive neuromuscular disease
* Decompensated respiratory failure (pH \< 7.35)
* Pregnancy
* Aged \<18, \>80
* Poor adherence to NIV (\<4hrs per night)
* Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

Where it's running

  • Guy's & St Thomas' NHS Foundation Trust
    London, London, United Kingdom
    Recruiting
  • Guy's and St. Thomas NHS Foundation Trust
    London, United Kingdom
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.