AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

Crossover Trial of VPAP (Variable Positive Airway Pressure) Ventilation Versus AutoVPAP in Neuromuscular and Chest Wall Disease: Effects on Nocturnal Hypoventilation, Sleep Quality and Tolerance

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252252

Enrollment

Registered

2005-11-11

Start date

2005-11-30

Completion date

2007-12-31

Last updated

2008-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Wall Disorder, Neuromuscular Disease

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).

Interventions

DEVICEVPAP non-invasive ventilator

DEVICEAutoVPAP non-invasive ventilator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026