AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation - Full Text View

Sponsors and Collaborators:	ResMed Royal Brompton Hospital NHS Trust
Information provided by:	ResMed
ClinicalTrials.gov Identifier:	NCT00252252

Purpose

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).

Condition	Intervention	Phase
Chest Wall Disorder Neuromuscular Disease	Device: VPAP non-invasive ventilator Device: AutoVPAP non-invasive ventilator	Phase I

MedlinePlus related topics: Neuromuscular Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
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

Further study details as provided by ResMed:

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

Enrollment:	20
Study Start Date:	November 2005
Study Completion Date:	December 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252252

Locations

United Kingdom, Greater London
Royal Brompton Hospital
London, Greater London, United Kingdom, SW3 6NP

Sponsors and Collaborators

ResMed

Royal Brompton Hospital NHS Trust

Investigators

Principal Investigator:

Anita Simonds, MD, FRCP

Royal Brompton Hospital NHS Trust

More Information

Study ID Numbers:	2005LF009B, REC Ref No 05/Q0404/001
Study First Received:	November 9, 2005
Last Updated:	June 20, 2008
ClinicalTrials.gov Identifier:	NCT00252252
Health Authority:	United Kingdom: Department of Health

Study placed in the following topic categories:

Neuromuscular Diseases
Hypoventilation

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009