Sleep Apnea SyndromesMeta IAHflowNCT04526366
Apnoea-Hypopnoea-Indices Determined Via Continuous Positive Airway Pressure vs Those Determined by Polysomnography
An observational study of Sleep Apnea Syndromes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
To date, no published systematic review and meta-analysis has compared AHI-CPAPflow and AHI-PSGgold. Therefore, the primary objective of this study is to compare published data for AHI-PSGgold and AHI-CPAPflow in patients treated by CPAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Continuous Positive Airway Pressure and Polysomnography
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2021to 31 May 2021
- Phase
- Observational
- 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
Study population: Adult patients treated with a CPAP-device and synchronous polysomnography.
Who may be able to join
- All (full scientific) study designs and publication types written in English and reporting Bland-Altman test results (or other tests suggesting the presence of the required data) between simultaneous, paired, polysomnography (PSG)-derived AND Continuous Positive Airway Pressure (CPAP)-derived data describing sleep disordered breathing.
Who cannot join
- Duplicates
- Does not refer to a full scientific article (e.g. case reports are excluded).
- Meta-analysis
- Paediatric populations (populations <18 years are excluded).
- Absence of appropriate paired results: synchronized polysomnography (PSG)-derived AND Continuous Positive Airway Pressure (CPAP)-derived data must be reported for ≥1 of the following measures: Apnoea-Hypopnoea-Indices (AHI), Apnoea-Indices (AI), Hypopnoea-Indices(HI), respiratory disturbance index (RDI), respiratory effort related arousals (RERA).
- Absence of appropriate test comparing paired results: the study must use ≥1 of the fol-lowing tests to compare the previously mentioned PSG-vs-CPAP-derived data: a bland-altman or correlation test, other conformity tests, tests of differences in centrality.
Show all 10Show fewer
- Inappropriate PSG scoring 1: PSG-derived variables must be coded following the American Academy of Sleep Medicine 2007 (or more recent) guidelines.
- Inappropriate PSG scoring 2: PSG-derived variables must be scored manually.
- Inappropriate PSG scoring 3: oxygen desaturation level used for scoring must be mentioned and at 3% or 4%.
- Inappropriate CPAP description: brand/device names must be mentioned.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Apnoea-Hypopnoea-Indices Determined Via Continuous Posi-tive Airway Pressure (AHI-CPAPflow) Versus Those Determined by Polysomnography (AHI-PSGgold): a Protocol for a Systematic Review and Meta-analysis
To date, no published systematic review and meta-analysis has compared AHI-CPAPflow and AHI-PSGgold. Therefore, the primary objective of this study is to compare published data for AHI-PSGgold and AHI-CPAPflow in patients treated by CPAP.
Read the detailed description
The secondary objectives are to evaluate, in a manner similar to the primary objective, data for apnoea indices (AI), hypopnoea indices (HI), respiratory disturbance indices (RDI) and respiratory effort related arousals (RERAs) and to perform subgroup analyses focusing on the inclusion/exclusion of central apnoea patients, BMI levels, CPAP device brands, pressure titration modes, use of a predetermined and fixed pressure level or not, and the impact of a 4%-PSG desaturation criteria versus 3%-PSG on index accuracy.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Continuous Positive Airway Pressure, Polysomnography
- Keywords
- apnoea hypopnoea index, CPAP
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Continuous Positive Airway Pressure device deployed for at least one night synchronously with polysomnography.
PolysomnographyDevice
Polysomnography deployed for at least one night synchronously with Continuous Positive Airway Pressure.
| Study group | Role | What they receive |
|---|---|---|
| The study population | All (full scientific) study designs and publication types written in English and reporting Bland-Altman test results (or other tests suggesting the presence of the required data) between simultaneous, paired, polysomnography (PSG)-derived AND Continuous Positive Airway Pressure (CPAP)-derived data describing sleep disordered breathing. Receives: Device: Continuous Positive Airway Pressure; Device: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean difference between AHI-CPAPflow and AHI-PSGgold
AHI-CPAPflow = Apnoea-Hypopnoea-Indices Determined Via Continuous Positive Airway Pressure AHI-PSGgold = Apnoea-Hypopnoea-Indices Determined by Polysomnography
Measured: Day 0
The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold
Measured: Day 0
Secondary outcomes (8)
The mean difference between AI-CPAPflow and AI-PSGgold
AI-CPAPflow = Apnoea--Indices Determined Via Continuous Positive Airway Pressure AI-PSGgold = Apnoea--Indices Determined by Polysomnography
Measured: Day 0
The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold
Measured: Day 0
The mean difference between HI-CPAPflow and HI-PSGgold
HI-CPAPflow = Hypopnoea--Indices Determined Via Continuous Positive Airway Pressure HI-PSGgold = Hypopnoea--Indices Determined by Polysomnography
Measured: Day 0
The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold
Measured: Day 0
The mean difference between RDI-CPAPflow and RDI-PSGgold
RDI-CPAPflow = Respiratory Disturbance Indices Determined Via Continuous Positive Airway Pressure RDI-PSGgold = Respiratory Disturbance Indices Determined by Polysomnography
Measured: Day 0
The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold
Measured: Day 0
The mean difference between RERA-CPAPflow and RERA-PSGgold
RERA-CPAPflow = Respiratory Effort Related Arousals Determined Via Continuous Positive Airway Pressure RERA-PSGgold = Respiratory Effort Related Arousals Determined by Polysomnography
Measured: Day 0
The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start31 Mar 2021
- Primary completion31 May 2021
- Study completion31 May 2021
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 Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dany Jaffuel, MD,PhD, Study director, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526366
- Sponsor's protocol ID
- RECHMPL20_0395
- Acronym
- Meta IAHflow
- Status last verified
- Oct 2021
- First submitted
- 21 Aug 2020
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertelli F, Suehs CM, Mallet JP, Rotty MC, Pepin JL, Gagnadoux F, Matzner-Lober E, Bourdin A, Molinari N, Jaffuel D. Apnoea-hypopnoea indices determined via continuous positive airway pressure (AHI-CPAPflow) versus those determined by polysomnography (AHI-PSGgold): a protocol for a systematic review and meta-analysis. BMJ Open. 2021 May 10;11(5):e044499. doi: 10.1136/bmjopen-2020-044499.
PubMed 33972338
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apnoea-Hypopnoea-Indices Determined Via Continuous Posi-tive Airway Pressure (AHI-CPAPflow) Versus Those Determined by Polysomnography (AHI-PSGgold): a Protocol for a Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT04526366
- Acronym / sponsor ID
- Meta IAHflow / RECHMPL20_0395
- Conditions
- Sleep Apnea Syndromes
- Keywords
- apnoea hypopnoea index, CPAP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 25 Aug 2020 (actual)
- 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.
To date, no published systematic review and meta-analysis has compared AHI-CPAPflow and AHI-PSGgold. Therefore, the primary objective of this study is to compare published data for AHI-PSGgold and AHI-CPAPflow in patients treated by CPAP.
Detailed description
The secondary objectives are to evaluate, in a manner similar to the primary objective, data for apnoea indices (AI), hypopnoea indices (HI), respiratory disturbance indices (RDI) and respiratory effort related arousals (RERAs) and to perform subgroup analyses focusing on the inclusion/exclusion of central apnoea patients, BMI levels, CPAP device brands, pressure titration modes, use of a predetermined and fixed pressure level or not, and the impact of a 4%-PSG desaturation criteria versus 3%-PSG on index accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Device: Continuous Positive Airway Pressure, Device: PolysomnographyAll (full scientific) study designs and publication types written in English and reporting Bland-Altman test results (or other tests suggesting the presence of the required data) between simultaneous, paired, polysomnography (PSG)-derived AND Continuous Positive Airway Pressure (CPAP)-derived data describing sleep disordered breathing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated with a CPAP-device and synchronous polysomnography.
Key inclusion criteria (1 listed)
- All (full scientific) study designs and publication types written in English and reporting Bland-Altman test results (or other tests suggesting the presence of the required data) between simultaneous, paired, polysomnography (PSG)-derived AND Continuous Positive Airway Pressure (CPAP)-derived data describing sleep disordered breathing.
Key exclusion criteria (10 listed)
- Duplicates
- Does not refer to a full scientific article (e.g. case reports are excluded).
- Meta-analysis
- Paediatric populations (populations <18 years are excluded).
- Absence of appropriate paired results: synchronized polysomnography (PSG)-derived AND Continuous Positive Airway Pressure (CPAP)-derived data must be reported for ≥1 of the following measures: Apnoea-Hypopnoea-Indices (AHI), Apnoea-Indices (AI), Hypopnoea-Indices(HI), respiratory disturbance index (RDI), respiratory effort related arousals (RERA).
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 |
|---|---|---|
| Continuous Positive Airway PressureContinuous Positive Airway Pressure device deployed for at least one night synchronously with polysomnography. | Device | The study population |
| PolysomnographyPolysomnography deployed for at least one night synchronously with Continuous Positive Airway Pressure. | Device | The study population |
Primary outcome
The mean difference between AHI-CPAPflow and AHI-PSGgold
Time frame: Day 0
AHI-CPAPflow = Apnoea-Hypopnoea-Indices Determined Via Continuous Positive Airway Pressure AHI-PSGgold = Apnoea-Hypopnoea-Indices Determined by Polysomnography
The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold
Time frame: Day 0
8 secondary outcomes
The mean difference between AI-CPAPflow and AI-PSGgold
Time frame: Day 0
The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold
Time frame: Day 0
The mean difference between HI-CPAPflow and HI-PSGgold
Time frame: Day 0
The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold
Time frame: Day 0
The mean difference between RDI-CPAPflow and RDI-PSGgold
Time frame: Day 0
The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold
Time frame: Day 0
The mean difference between RERA-CPAPflow and RERA-PSGgold
Time frame: Day 0
The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold
Time frame: Day 0
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 19 Oct 2021.
- Background: PubMed 33972338Bertelli F, Suehs CM, Mallet JP, Rotty MC, Pepin JL, Gagnadoux F, Matzner-Lober E, Bourdin A, Molinari N, Jaffuel D. Apnoea-hypopnoea indices determined via continuous positive airway pressure (AHI-CPAPflow) versus those determined by polysomnography (AHI-PSGgold): a protocol for a systematic review and meta-analysis. BMJ Open. 2021 May 10;11(5):e044499. doi: 10.1136/bmjopen-2020-044499.
- Meta IAHflow on the Open Science Framework.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Dany Jaffuel, MD,PhD study director
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 10 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 19 Oct 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 France. 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?
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?
The mean difference between AHI-CPAPflow and AHI-PSGgold (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT04526366, 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 19 Oct 2021.