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

• ClinicalTrials.gov Identifier: NCT04526366
• Recruitment Status: Completed
• First Posted: August 25, 2020
• Last Update Posted: October 19, 2021
• Sponsor: University Hospital, Montpellier
• 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 ]

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-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.

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

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