NCT06339580

Brief Summary

Assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

April 9, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

March 25, 2024

Last Update Submit

May 17, 2024

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

  • Mean overnight transcutaneous carbon dioxide

    Average carbon dioxide level overnight

    2 night

Secondary Outcomes (5)

  • Maximum overnight transcutaneous carbon dioxide

    2 night

  • Overnight desaturation index

    2 night

  • Visual analogue scale of sleep comfort

    2 night

  • Health-related quality of life

    3 months

  • Adherence to ventilation

    3 months

Study Arms (1)

VT-NMD arm

EXPERIMENTAL

all patients will be trialed on volume targeted non invasive ventilation

Device: Volume-targeted non-invasive ventilation

Interventions

Volume-targeted non-invasive ventilationDEVICE

A target tidal volume is set on the ventilation device, and the device will then automatically adjust delivered pressures to reach this target tidal volume.

VT-NMD arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Guy's and St. Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

RECRUITING

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Patrick Murphy

CONTACT

02071888070Patrick.murphy@gstt.nhs.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

April 9, 2024

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

May 20, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)