Clinical Trials Directory

Trials / Completed

CompletedNCT04526366

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
1 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEContinuous Positive Airway PressureContinuous Positive Airway Pressure device deployed for at least one night synchronously with polysomnography.
DEVICEPolysomnographyPolysomnography deployed for at least one night synchronously with Continuous Positive Airway Pressure.

Timeline

Start date
2021-03-31
Primary completion
2021-05-31
Completion
2021-05-31
First posted
2020-08-25
Last updated
2021-10-19

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04526366. Inclusion in this directory is not an endorsement.