AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

Phase 1

Completed

• Conditions: Chest Wall Disorder; Neuromuscular Disease

• Registration Number: NCT00252252
• Lead Sponsor: ResMed

Brief Summary

The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory disorders (eg. neuromuscular disease or chest wall disorder).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-09
• Study First Posted: 2005-11-11
• Primary Completion: 2007-06
• Study Completion: 2007-12
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-20
• Last Update Posted: 2008-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patients aged 18-80 years
• Nocturnal hypoventilation (nocturnal peak transcutaneous PCO2 > 6.5 kPa when breathing spontaneously) with
• Congenital neuromuscular disease (eg. Duchenne muscular dystrophy, congenital muscular dystrophy), acquired neuromuscular disease (eg. old polio, bilateral diaphragm paralysis) or chest wall disease (eg. idiopathic scoliosis, thoracoplasty)
• Recruited from 1300 patients attending Royal Brompton Hospital Lind ward ventilator clinic.
• All patients will be familiar with non-invasive ventilation use but currently using a ventilator which is not a VPAP model eg. BiPAP Harmony, Breas PV403.
• Able to understand treatment and protocol

Exclusion Criteria

• Unstable respiratory failure (PaO2 < 7.5 kPa, PaCO2 > 8.0 kPa,
• Uncontrolled heart failure or arrhythmia
• Moderate or severe bulbar weakness.
• Unable to understand treatment or protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.

Secondary Outcome Measures

Name	Time	Method
Compare effects on overnight heart rate variation (as a measure of autonomic stress)
Measure of effect on daytime sleepiness
Compare tolerance of AutoVPAP versus standard VPAP
Measure of hours of use of device

Trial Locations

Locations (1)

Royal Brompton Hospital; 🇬🇧 London, Greater London, United Kingdom