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AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

Primary Purpose

Chest Wall Disorder, Neuromuscular Disease

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
VPAP non-invasive ventilator
AutoVPAP non-invasive ventilator
Sponsored by
ResMed
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chest Wall Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Royal Brompton Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2005
Last Updated
June 20, 2008
Sponsor
ResMed
Collaborators
Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00252252
Brief Title
AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ResMed
Collaborators
Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Wall Disorder, Neuromuscular Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
VPAP non-invasive ventilator
Intervention Type
Device
Intervention Name(s)
AutoVPAP non-invasive ventilator
Primary Outcome Measure Information:
Title
Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.
Secondary Outcome Measure Information:
Title
Compare tolerance of AutoVPAP versus standard VPAP
Title
Compare effects on overnight heart rate variation (as a measure of autonomic stress)
Title
Measure of hours of use of device
Title
Measure of effect on daytime sleepiness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Simonds, MD, FRCP
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19251798
Citation
Jaye J, Chatwin M, Dayer M, Morrell MJ, Simonds AK. Autotitrating versus standard noninvasive ventilation: a randomised crossover trial. Eur Respir J. 2009 Mar;33(3):566-71. doi: 10.1183/09031936.00065008.
Results Reference
derived

Learn more about this trial

AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

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