COPDPhase 2NCT02444806
PSG Versus Oxim-capnography to Setup Home NIV
A Phase 2 study testing Full polysomnography and Oximetry-capnography in people with COPD and OSA, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Full polysomnography and Oximetry-capnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Mar 2016
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD (as defined by GOLD criteria[4])
- OSA (ODI > 7.5 events/hr, AHI > 5events/hr)
- PaCO2 > 6 kPa
- BMI > 30 kg/m2
Who cannot join
- Decompensated respiratory failure (pH < 7.35)
- Inability to tolerate NIV (< 4 hours usage at in hospital titration)
- Contraindication to NIV
- Pregnancy
- Aged <18
- Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol
About this study
Official title: The Clinical Effectiveness of PSG Versus Limited Respiratory Polygraphy During NIV Set up in COPD-OSA Overlap Syndrome: A Randomised Controlled Trial
The study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.
Read the detailed description
With limited comparative data to support the different strategies, there is substantial variation across Europe and the United States in the methods used by clinicians to set up home non-invasive ventilation (NIV) for patients with chronic respiratory failure as a consequence of sleep disordered breathing. Indeed with few data to support the practice, many centres employ full montage polysomnography, which is not only a significant physical burden to the patient but also a financial burden to the healthcare provider in terms of the facilities required, staff training and equipment.
The investigators propose to undertake a randomised controlled trial to compare the clinical effectiveness, in terms of the change in daytime arterial partial pressure of carbon dioxide (PaCO2) at 3 months, of limited respiratory polygraphy and full polysomnography to set up NIV in patients with COPD-OSA overlap. Secondary outcome measures at 3 months will include overnight control of gas exchange, subjective sleep quality, health related quality of life and ventilator adherence. COPD-OSA overlap are a patient group that have a rising prevalence with limited data currently available detailing NIV set up, which wholly supports the rationale of using this increasingly important group as a target population for this trial.
- Being tested
- Full polysomnography, Oximetry-capnography
- Keywords
- Sleep disordered breathing, Domiciliary NIV
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full polysomnographyOther
Also called Polysomnography
Full sleep and respiratory monitoring with EEG
Oximetry-capnographyOther
Also called Limited respiratory monitoring
Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration.
| Study group | Role | What they receive |
|---|---|---|
| Full Polysomnography | Active comparator | Patients will have NIV settings established using overnight full polysomnography. Receives: Other: Full polysomnography |
| Oximetry-capnography | Active comparator | Patients will have NIV settings established using only Oximetry-capnography and subjective sleep comfort. Receives: Other: Oximetry-capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaCO2 (Arterial blood gas analysis)
Arterial blood gas analysis
Measured: 3 months
Secondary outcomes (6)
Health related quality of life (CAT, SRI)
CAT, SRI
Measured: 3 months
Spirometry (FEV1, FVC)
FEV1, FVC
Measured: 3 months
Subjective sleep comfort (VAS)
VAS
Measured: 3 months
Objective sleep comfort (Actigraphy)
Actigraphy
Measured: 3 months
Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara)
Invasive respiratory mechanics performed on discharge NIV settings to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara
Measured: Day 1
NIV compliance (machine recorded)
NIV machine recorded compliance
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startJan 2015
- Primary completionNov 2015
- Study completionMar 2016
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 COPDStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Rouen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444806
- Sponsor's protocol ID
- 14/LO/2088
- Status last verified
- Jul 2016
- First submitted
- 12 May 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Patout M, Arbane G, Cuvelier A, Muir JF, Hart N, Murphy PB. Polysomnography versus limited respiratory monitoring and nurse-led titration to optimise non-invasive ventilation set-up: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):83-86. doi: 10.1136/thoraxjnl-2017-211067. Epub 2018 Mar 30.
PubMed 29602814
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Effectiveness of PSG Versus Limited Respiratory Polygraphy During NIV Set up in COPD-OSA Overlap Syndrome: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02444806
- Acronym / sponsor ID
- 14/LO/2088
- Keywords
- Sleep disordered breathing, Domiciliary NIV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospital, Rouen
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 May 2015 (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 study aims to compare 2 different strategies used to setup non-invasive ventilation in patients with OCPD-OSA overlap.
Detailed description
With limited comparative data to support the different strategies, there is substantial variation across Europe and the United States in the methods used by clinicians to set up home non-invasive ventilation (NIV) for patients with chronic respiratory failure as a consequence of sleep disordered breathing. Indeed with few data to support the practice, many centres employ full montage polysomnography, which is not only a significant physical burden to the patient but also a financial burden to the healthcare provider in terms of the facilities required, staff training and equipment.
The investigators propose to undertake a randomised controlled trial to compare the clinical effectiveness, in terms of the change in daytime arterial partial pressure of carbon dioxide (PaCO2) at 3 months, of limited respiratory polygraphy and full polysomnography to set up NIV in patients with COPD-OSA overlap. Secondary outcome measures at 3 months will include overnight control of gas exchange, subjective sleep quality, health related quality of life and ventilator adherence. COPD-OSA overlap are a patient group that have a rising prevalence with limited data currently available detailing NIV set up, which wholly supports the rationale of using this increasingly important group as a target population for this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full Polysomnography | Active comparator | Other: Full polysomnographyPatients will have NIV settings established using overnight full polysomnography. |
| Oximetry-capnography | Active comparator | Other: Oximetry-capnographyPatients will have NIV settings established using only Oximetry-capnography and subjective sleep comfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD (as defined by GOLD criteria[4])
- OSA (ODI > 7.5 events/hr, AHI > 5events/hr)
- PaCO2 > 6 kPa
- BMI > 30 kg/m2
Key exclusion criteria (6 listed)
- Decompensated respiratory failure (pH < 7.35)
- Inability to tolerate NIV (< 4 hours usage at in hospital titration)
- Contraindication to NIV
- Pregnancy
- Aged <18
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 |
|---|---|---|
| Full polysomnographyAlso: PolysomnographyFull sleep and respiratory monitoring with EEG | Other | Full Polysomnography |
| Oximetry-capnographyAlso: Limited respiratory monitoringLimited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration. | Other | Oximetry-capnography |
Primary outcome
PaCO2 (Arterial blood gas analysis)
Time frame: 3 months
Arterial blood gas analysis
6 secondary outcomes
Health related quality of life (CAT, SRI)
Time frame: 3 months
Spirometry (FEV1, FVC)
Time frame: 3 months
Subjective sleep comfort (VAS)
Time frame: 3 months
Objective sleep comfort (Actigraphy)
Time frame: 3 months
Respiratory mechanics (to include, work of breathing, PEEPdyn, Cdyn, EMGdi, EMGpara)
Time frame: Day 1
NIV compliance (machine recorded)
Time frame: 3 months
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 12 Jul 2016.
- Derived from this study: PubMed 29602814Patout M, Arbane G, Cuvelier A, Muir JF, Hart N, Murphy PB. Polysomnography versus limited respiratory monitoring and nurse-led titration to optimise non-invasive ventilation set-up: a pilot randomised clinical trial. Thorax. 2019 Jan;74(1):83-86. doi: 10.1136/thoraxjnl-2017-211067. Epub 2018 Mar 30.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Full polysomnography and Oximetry-capnography in people with COPD and OSA, run by Guy's and St Thomas' NHS Foundation Trust.
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 4 inclusion and 6 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 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
PaCO2 (Arterial blood gas analysis) (time frame: 3 months). 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 NCT02444806, 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 12 Jul 2016.