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

Sleep Apnea Syndromes Clinical Trial

— Meta IAHflow  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04526366
• Other study ID #: RECHMPL20_0395
• Status: Completed
• Start date: March 31, 2021
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes

Intervention

Device:
• Continuous Positive Airway Pressure
Continuous Positive Airway Pressure device deployed for at least one night synchronously with polysomnography.
• Polysomnography
Polysomnography deployed for at least one night synchronously with Continuous Positive Airway Pressure.

Locations

Country	Name	City	State
France	University Hospitals of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (1)

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-CPAP(flow)) versus those determined by polysomnography (AHI-PSG(gold)): a protocol for a systematic review and meta-analysis. BMJ Open. 2021 May 10;11(5):e044499. doi: 10.1136/bmjopen-2020-044499. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold		Day 0
Secondary	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
Secondary	The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold		Day 0
Secondary	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
Secondary	The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold		Day 0
Secondary	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
Secondary	The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold		Day 0
Secondary	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
Secondary	The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold		Day 0

External Links

•   Meta IAHflow on the Open Science Framework.