Apnoea-Hypopnoea-Indices Determined Via Continuous Positive Airway Pressure vs Those Determined by Polysomnography (Meta IAHflow)

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes
• Intervention / Treatment: Device: Continuous Positive Airway Pressure; Device: Polysomnography

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 Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34925
    • University Hospitals of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients treated with a CPAP-device and synchronous polysomnography.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Continuous Positive Airway Pressure; Continuous Positive Airway Pressure device deployed for at least one night synchronously with polysomnography.; Device: Polysomnography; Polysomnography deployed for at least one night synchronously with Continuous Positive Airway Pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold		Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold		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	Day 0
The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold		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	Day 0
The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold		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	Day 0
The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold		Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Dany Jaffuel, MD,PhD, University Hospitals of Montpellier

Publications and helpful links

General 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.

Helpful Links

• Meta IAHflow on the Open Science Framework.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: CPAP; apnoea hypopnoea index
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Apnea
• Other Study ID Numbers: RECHMPL20_0395

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No