Clinical trial NCT04526366: Apnoea-Hypopnoea-Indices Determined Via Continuous Positive Airway Pressure vs Those Determined by Polysomnography
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes
Keywords: apnoea hypopnoea index
CPAP
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients treated with a CPAP-device and synchronous polysomnography.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: The mean difference between AHI-CPAPflow and AHI-PSGgold
timeFrame: Day 0
measure: The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold
timeFrame: Day 0
Secondary outcomes:
measure: The mean difference between AI-CPAPflow and AI-PSGgold
timeFrame: Day 0
measure: The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold
timeFrame: Day 0
measure: The mean difference between HI-CPAPflow and HI-PSGgold
timeFrame: Day 0
measure: The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold
timeFrame: Day 0
measure: The mean difference between RDI-CPAPflow and RDI-PSGgold
timeFrame: Day 0
measure: The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold
timeFrame: Day 0
measure: The mean difference between RERA-CPAPflow and RERA-PSGgold
timeFrame: Day 0
measure: The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospitals of Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Dany Jaffuel, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.