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

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: Continuous Positive Airway Pressure; Device: Polysomnography

• Registration Number: NCT04526366
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-25
• Study Start: 2021-03-31
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Continuous Positive Airway Pressure	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.
The study population	Polysomnography	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.

Primary Outcome Measures

Name	Time	Method
The mean difference between AHI-CPAPflow and AHI-PSGgold	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	Day 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospitals of Montpellier; 🇫🇷 Montpellier, France