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Apnoea-Hypopnoea-Indices Determined Via Continuous Positive Airway Pressure vs Those Determined by Polysomnography

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04526366
Acronym
Meta IAHflow
Enrollment
1
Registered
2020-08-25
Start date
2021-03-31
Completion date
2021-05-31
Last updated
2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

Keywords

apnoea hypopnoea index, CPAP

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.

Interventions

DEVICEContinuous Positive Airway Pressure

Continuous Positive Airway Pressure device deployed for at least one night synchronously with polysomnography.

DEVICEPolysomnography

Polysomnography deployed for at least one night synchronously with Continuous Positive Airway Pressure.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The mean difference between AHI-CPAPflow and AHI-PSGgoldDay 0AHI-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-PSGgoldDay 0

Secondary

MeasureTime frameDescription
The mean difference between HI-CPAPflow and HI-PSGgoldDay 0HI-CPAPflow = Hypopnoea--Indices Determined Via Continuous Positive Airway Pressure HI-PSGgold = Hypopnoea--Indices Determined by Polysomnography
The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgoldDay 0
The mean difference between RDI-CPAPflow and RDI-PSGgoldDay 0RDI-CPAPflow = Respiratory Disturbance Indices Determined Via Continuous Positive Airway Pressure RDI-PSGgold = Respiratory Disturbance Indices Determined by Polysomnography
The mean difference between AI-CPAPflow and AI-PSGgoldDay 0AI-CPAPflow = Apnoea--Indices Determined Via Continuous Positive Airway Pressure AI-PSGgold = Apnoea--Indices Determined by Polysomnography
The mean difference between RERA-CPAPflow and RERA-PSGgoldDay 0RERA-CPAPflow = Respiratory Effort Related Arousals Determined Via Continuous Positive Airway Pressure RERA-PSGgold = Respiratory Effort Related Arousals Determined by Polysomnography
The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgoldDay 0
The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgoldDay 0
The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgoldDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026