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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

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.

Condition or disease Intervention/treatment
Sleep Apnea Syndromes 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.

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Other
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
Actual Study Start Date : March 31, 2021
Actual Primary Completion Date : May 31, 2021
Actual Study Completion Date : May 31, 2021

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.




Primary Outcome Measures :
  1. 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

  2. The standard deviation for the mean difference between AHI-CPAPflow and AHI-PSGgold [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. 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

  2. The standard deviation for the mean difference between AI-CPAPflow and AI-PSGgold [ Time Frame: Day 0 ]
  3. 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

  4. The standard deviation for the mean difference between HI-CPAPflow and HI-PSGgold [ Time Frame: Day 0 ]
  5. 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

  6. The standard deviation for the mean difference between RDI-CPAPflow and RDI-PSGgold [ Time Frame: Day 0 ]
  7. 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

  8. The standard deviation for the mean difference between RERA-CPAPflow and RERA-PSGgold [ Time Frame: Day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients treated with a CPAP-device and synchronous polysomnography.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526366


Locations
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France
University Hospitals of Montpellier
Montpellier, France, 34925
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Dany Jaffuel, MD,PhD University Hospitals of Montpellier
Additional Information:
Publications:
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04526366    
Other Study ID Numbers: RECHMPL20_0395
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
apnoea hypopnoea index
CPAP
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases