Nocturnal HypoventilationNCT00901485
Autotitrating Versus Standard Non-invasive Ventilation (NIV) in Newly Diagnosed Patients
A study testing AutoVPAP and VPAPIIIST-A in people with Nocturnal Hypoventilation and Neuromuscular Disease, run by ResMed at 1 site in United Kingdom.
Trial summary
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nocturnal Hypoventilation, Neuromuscular Disease, Chest Wall Disorder
- What is being tested?
- AutoVPAP and VPAPIIIST-A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- new clinical diagnosis of nocturnal hypoventilation
- requirement for long-term domiciliary non-invasive ventilation
- no previous experience with domiciliary non-invasive ventilation
Who cannot join
- uncontrolled cardiac failure
- acute exacerbation of respiratory failure
- daytime resting PaO2 < 7.5kPa
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Newly Diagnosed Hypoventilation
The aim of the study is to compare the efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV.
Read the detailed description
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients newly diagnosed with nocturnal hypoventilation who are inexperienced in the use of noninvasive ventilation (NIV). NIV is standard therapy for patients with nocturnal hypoventilation.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 referred to, or under follow up at, the Royal Brompton Hospital who require domiciliary NIV but are inexperienced with use of NIV will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. At the end of one month the patient will be swapped to the alternative NIV for a further one month of domiciliary NIV treatment. At the end of each one month treatment period the patient will undergo overnight polysomnography, transcutaneous CO2 monitoring and 24 hour Holter monitoring.
- Being tested
- AutoVPAP, VPAPIIIST-A
- Keywords
- Respiratory insufficiency, Hypercapnia, Hypoventilation, Sleep, Polysomnography, Hypoxia, Titration, Non Invasive Ventilation
- Medical subject headings
- Neuromuscular Diseases, Respiratory Insufficiency, Hypercapnia, Hypoventilation, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoVPAPDevice
Also called autotitrating variable positive airway pressure, autotitrating NIV, automatically titrating NIV
Automatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home.
VPAPIIIST-ADevice
Also called standard NIV, standard non-invasive ventilator, variable positive airway pressure, VPAP
Standard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home.
| Study group | Role | What they receive |
|---|---|---|
| autotitrating NIV | Experimental | approximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation Receives: Device: AutoVPAP |
| Standard non-invasive ventilation | Active comparator | approximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation Receives: Device: VPAPIIIST-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overnight Mean Oxygen Saturation
Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.
Measured: 4 weeks
Secondary outcomes (4)
Overnight Mean Transcutaneous Carbon Dioxide
Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.
Measured: 4 weeks
Overnight Peak Transcutaneous Carbon Dioxide
Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.
Measured: 4 weeks
Oxygen Desaturation Index (>4%)
Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy. ODI is the number of events per hour that SaO2 drops by >4%.
Measured: 4 weeks
Sleep Quality: Arousal Index
A full PSG was performed during a sleep a on NIV at the end of each month's NIV therapy. Standard polysomnography analysis was performed by two team members blinded to patient identity and ventilator mode (REP/JJ).
Sleep quality was assessed by the Arousal Index (no of arousals/hour)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nocturnal HypoventilationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Anita Simonds, MD, FRCP, Principal investigator, Royal Brompton & Harefield Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901485
- Sponsor's protocol ID
- 08/H0708/16
- Other IDs
- R&D No. 2008/LF017B
- Status last verified
- May 2021
- First submitted
- 14 Jan 2009
- Last updated
- 18 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autotitrating Non-invasive Ventilation (NIV) Versus Standard NIV; a Randomised Crossover Trial in Patients With Newly Diagnosed Hypoventilation
- ClinicalTrials.gov ID
- NCT00901485
- Acronym / sponsor ID
- 08/H0708/16
- Keywords
- Respiratory insufficiency, Hypercapnia, Hypoventilation, Sleep, Polysomnography, Hypoxia, Titration, Non Invasive Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Posted 18 Jun 2021
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 efficacy and tolerance of autotitrating non-invasive ventilation (NIV) versus standard NIV in patients with newly diagnosed nocturnal hypoventilation who have never experienced nocturnal, home NIV.
Detailed description
The aim of the study is to compare the effect of two types of noninvasive ventilator (a small machine that assists breathing) in patients newly diagnosed with nocturnal hypoventilation who are inexperienced in the use of noninvasive ventilation (NIV). NIV is standard therapy for patients with nocturnal hypoventilation.
The most common type of NIV is bilevel pressure support which assists patient breathing by delivering different levels of air pressure during inspiration and expiration via a mask covering the nose or nose and mouth. Standard bilevel NIV (VPAP™) has been further developed to create a new automatically adjusting NIV (AutoVPAP™). Automatically adjusting NIV varies the inspiratory air pressure according to the airflow rates generated by the patient. This may improve patient comfort, hours of NIV use and recovery time.
Patients over the age of 18 referred to, or under follow up at, the Royal Brompton Hospital who require domiciliary NIV but are inexperienced with use of NIV will be considered for entry into this randomised crossover study. If eligible for inclusion and willing to take part patients will be setup on automatically adjusting NIV or standard NIV, assigned in random order. At the end of one month the patient will be swapped to the alternative NIV for a further one month of domiciliary NIV treatment. At the end of each one month treatment period the patient will undergo overnight polysomnography, transcutaneous CO2 monitoring and 24 hour Holter monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autotitrating NIV | Experimental | Device: AutoVPAPapproximately 6 weeks using domiciliary nocturnal autotitrating non-invasive ventilation |
| Standard non-invasive ventilation | Active comparator | Device: VPAPIIIST-Aapproximately 6 weeks using domiciliary nocturnal standard non-invasive ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- new clinical diagnosis of nocturnal hypoventilation
- requirement for long-term domiciliary non-invasive ventilation
- no previous experience with domiciliary non-invasive ventilation
Key exclusion criteria (5 listed)
- uncontrolled cardiac failure
- acute exacerbation of respiratory failure
- daytime resting PaO2 < 7.5kPa
- moderate or severe bulbar weakness
- inability to understand rationale and/or consent form for study
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 |
|---|---|---|
| AutoVPAPAlso: autotitrating variable positive airway pressure, autotitrating NIV, automatically titrating NIVAutomatically titrated non-invasive ventilator, with target gross alveolar ventilation and back up respiratory rate determined by learn function. Nocturnal use for one month in patient's home. | Device | autotitrating NIV |
| VPAPIIIST-AAlso: standard NIV, standard non-invasive ventilator, variable positive airway pressure, VPAPStandard non-invasive ventilator with pressure and respiratory rate settings determined by healthcare professional. Nocturnal use for one month in the patient's home. | Device | Standard non-invasive ventilation |
Primary outcome
Overnight Mean Oxygen Saturation
Time frame: 4 weeks
Overnight oximetry (SaO2) and transcutaneous capnography (PtcCO2) (TOSCA, Linde Medical Sensors, Switzerland) were performed during a sleep a on NIV at the end of each month's NIV therapy.
4 secondary outcomes
Overnight Mean Transcutaneous Carbon Dioxide
Time frame: 4 weeks
Overnight Peak Transcutaneous Carbon Dioxide
Time frame: 4 weeks
Oxygen Desaturation Index (>4%)
Time frame: 4 weeks
Sleep Quality: Arousal Index
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Prevalence of Nocturnal Hypoventilation in Obese Subjects Fiited With Continuous Positive Airway Pressure for Obstructive Sleep Apnea / Hypopnea Syndrome
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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 Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoVPAP and VPAPIIIST-A in people with Nocturnal Hypoventilation 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 3 inclusion and 5 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 18 Jun 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overnight Mean Oxygen Saturation (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2021.