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

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ClinicalTrials.gov Identifier: NCT04526366
Recruitment Status : Completed
First Posted : August 25, 2020
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date August 21, 2020
First Posted Date August 25, 2020
Last Update Posted Date October 19, 2021
Actual Study Start Date March 31, 2021
Actual Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2020)
  • 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
  • The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold [ Time Frame: Day 0 ]
Original Primary Outcome Measures
 (submitted: August 24, 2020)
  • 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
  • The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold measures [ Time Frame: Day 0 ]
Change History
Current Secondary Outcome Measures
 (submitted: August 25, 2020)
  • 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
  • The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold [ Time Frame: Day 0 ]
  • 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
  • The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold [ Time Frame: Day 0 ]
  • 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
  • The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold [ Time Frame: Day 0 ]
  • 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
  • The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold [ Time Frame: Day 0 ]
Original Secondary Outcome Measures
 (submitted: August 24, 2020)
  • 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
  • The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold measures [ Time Frame: Day 0 ]
  • 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
  • The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold measures [ Time Frame: Day 0 ]
  • 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
  • The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold measures [ Time Frame: Day 0 ]
  • 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
  • The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold measures [ Time Frame: Day 0 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Apnoea-Hypopnoea-Indices Determined Via Continuous Positive Airway Pressure vs Those Determined by Polysomnography
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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Adult patients treated with a CPAP-device and synchronous polysomnography.
Condition Sleep Apnea Syndromes
Intervention
  • 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.
Study Groups/Cohorts 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.
Interventions:
  • Device: Continuous Positive Airway Pressure
  • Device: Polysomnography
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-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 24, 2020)
1
Original Estimated Enrollment Same as current
Actual Study Completion Date May 31, 2021
Actual Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04526366
Other Study ID Numbers RECHMPL20_0395
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party University Hospital, Montpellier
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Montpellier
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Dany Jaffuel, MD,PhD University Hospitals of Montpellier
PRS Account University Hospital, Montpellier
Verification Date October 2021