Chest Wall DisorderPhase 1NCT00252252
AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation
A Phase 1 study testing VPAP non-invasive ventilator and AutoVPAP non-invasive ventilator in people with Chest Wall Disorder and Neuromuscular Disease, run by ResMed at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chest Wall Disorder, Neuromuscular Disease
- What is being tested?
- VPAP non-invasive ventilator and AutoVPAP non-invasive ventilator
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2005to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton Hospital
London, Greater London, SW3 6NP
About this 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
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).
- Conditions
- Chest Wall Disorder, Neuromuscular Disease
- Being tested
- VPAP non-invasive ventilator, AutoVPAP non-invasive ventilator
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPAP non-invasive ventilatorDevice
AutoVPAP non-invasive ventilatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionJun 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest Wall DisorderStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Investigators
- Anita Simonds, MD, FRCP, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252252
- Sponsor's protocol ID
- 2005LF009B
- Other IDs
- REC Ref No 05/Q0404/001
- Status last verified
- Jun 2008
- First submitted
- 9 Nov 2005
- Last updated
- 24 Jun 2008
- Results posted
- No
Publications
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.
PubMed 19251798
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00252252
- Acronym / sponsor ID
- 2005LF009B
- Conditions
- Chest Wall Disorder, Neuromuscular Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Nov 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 11 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPAP non-invasive ventilator | Device | – |
| AutoVPAP non-invasive ventilator | Device | – |
Primary outcome
Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.
4 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2008.
- Derived from this study: PubMed 19251798Jaye 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Simonds, MD, FRCP principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VPAP non-invasive ventilator and AutoVPAP non-invasive ventilator in people with Chest Wall Disorder and Neuromuscular Disease, run by ResMed at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare objective measures of sleep, sleep related ventilation and daytime respiratory function between the two treatment devices, VPAP and AutoVPAP.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00252252, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2008.