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

NCT04526366 | Completed

• 1 other identifier: RECHMPL20_0395
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes

Keywords

apnoea hypopnoea index; CPAP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• The mean difference between AI-CPAPflow and AI-PSGgold

  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

  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

  Day 0

Study Arms (1)

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; Device: Polysomnography

Interventions

Continuous Positive Airway Pressure DEVICE

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

The study population

Polysomnography DEVICE

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

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospitals of Montpellier

Montpellier, 34925, France

Location

Related 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-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.

  PMID: 33972338 BACKGROUND

Related Links

• Meta IAHflow on the Open Science Framework.

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure; Polysomnography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Dany Jaffuel, MD,PhD

  University Hospitals of Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: March 31, 2021
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)