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
2 other identifiers
interventional
20
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJune 24, 2008
June 1, 2008
1.6 years
November 9, 2005
June 20, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ResMedlead
- Royal Brompton & Harefield NHS Foundation Trustcollaborator
Study Sites (1)
Royal Brompton Hospital
London, Greater London, SW3 6NP, United Kingdom
Related Publications (1)
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.
PMID: 19251798DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anita Simonds, MD, FRCP
Royal Brompton & Harefield NHS Foundation Trust
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
November 1, 2005
Primary Completion
June 1, 2007
Study Completion
December 1, 2007
Last Updated
June 24, 2008
Record last verified: 2008-06