AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

ResMed20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chest Wall Disorder Neuromuscular Disease

Interventions

VPAP non-invasive ventilatorDEVICE

AutoVPAP non-invasive ventilatorDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Royal Brompton Hospital

London, Greater London, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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