AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation | NCT00252252

Studies
AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation

NCT00252252

Sponsor

ResMed

Status

Completed

Last Update Posted

Jun 24, 2008Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Chest Wall Disorder
Neuromuscular Disease

Interventions

VPAP non-invasive ventilator
AutoVPAP non-invasive ventilator

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
REC Ref No 05/Q0404/001

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Jun 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Nov 9, 2005

First Submission Date that Met QC Criteria

Nov 9, 2005

First Posted Date

Nov 11, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2008

Last Update Posted Date

Jun 24, 2008Estimated

Name	Class
Royal Brompton & Harefield NHS Foundation Trust	OTHER

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anita Simonds, MD, FRCP	Royal Brompton & Harefield NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Brompton Hospital		London	Greater London	SW3 6NP	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19251798	Derived	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.

Name	Type	Description	Arm Group Labels	Other Names
VPAP non-invasive ventilator	Device
AutoVPAP non-invasive ventilator	Device