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Completed

NCT Number: NCT04526366

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of Montpellier

Montpellier, 34925, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Positive Airway Pressure

Device

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

Polysomnography

Device

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

Primary outcomes

  1. 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

  2. The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold

    Time frame: Day 0

Secondary outcomes

  1. The mean difference between AI-CPAPflow and AI-PSGgold

    Time frame: Day 0

    AI-CPAPflow = Apnoea--Indices Determined Via Continuous Positive Airway Pressure AI-PSGgold = Apnoea--Indices Determined by Polysomnography

  2. The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold

    Time frame: Day 0

  3. The mean difference between HI-CPAPflow and HI-PSGgold

    Time frame: Day 0

    HI-CPAPflow = Hypopnoea--Indices Determined Via Continuous Positive Airway Pressure HI-PSGgold = Hypopnoea--Indices Determined by Polysomnography

  4. The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold

    Time frame: Day 0

  5. The mean difference between RDI-CPAPflow and RDI-PSGgold

    Time frame: Day 0

    RDI-CPAPflow = Respiratory Disturbance Indices Determined Via Continuous Positive Airway Pressure RDI-PSGgold = Respiratory Disturbance Indices Determined by Polysomnography

  6. The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold

    Time frame: Day 0

  7. The mean difference between RERA-CPAPflow and RERA-PSGgold

    Time frame: Day 0

    RERA-CPAPflow = Respiratory Effort Related Arousals Determined Via Continuous Positive Airway Pressure RERA-PSGgold = Respiratory Effort Related Arousals Determined by Polysomnography

  8. The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: Meta IAHflow

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2020
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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