OSA Homemonitoring

Study Overview
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Brief Summary
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Up to now, no studies are available where a comparison has been made between the accuracy of, on the one hand, the gold standard PSG and, on the other hand, a home monitoring sleep apnea-diagnostic system, consisting of a pulse oximeter, and accelerometer, a smartphone for snoring analysis, and a mattress for ballistocardiographic (BCG) recordings. The purpose of this study is twofold. On the one hand, a comparison between the predictive performance of an automated home monitoring system and the gold standard PSG in sleep apnea diagnosis will be performed. The home monitoring system consists of a pulse oximeter, an accelerometer, a smartphone to record ambient sound, and a mattress to record the BCG signal. This system will be provided by KU Leuven and Equilli, two partners that work together with the Sleep Laboratory at UZ Leuven and the group STADIUS of the KU Leuven in the OSA+ project. The system performs automated signal processing and classification in order to determine the presence of sleep apnea events. On the other hand, this study aims to improve the phenotyping of patients suffering from sleep apnea. This task will be first developed using the classical PSG and later an evaluation will be performed on the less obtrusive system.

Official Title
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OSA Homemonitoring

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Diagnostic Test: Homemonitoring diagnostic system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred to the sleep lab for a diagnostic polysomnography because of suspicion of sleep apnea will be considered to participate in the trial upon signature of the informed consent. Exclusion Criteria: Patients younger than 18 years

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSA Homemonitoring<br>Homemonitoring diagnostic system | Diagnostic Test: Homemonitoring diagnostic system<br>* In addition to the standard full-night diagnostic polysomnography, patients will be evaluated during the same night with a homemonitoring diagnostic system that consists out of a pulse oximeter, accelerometer, smartphone for audio recording and a mattress that measures the ballistocardiogram.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of the homemonitoring system | Accuracy of the homemonitoring system of apnea/hypopnea index measurement (in comparison with gold standard) polysomnography) | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular risk prediction tool | The homemonitoring system will lead to new signals that could better predict cardiovascular risk in comparison with the apnea/hypopnea index of the polysomnography. This tool will be based on a new algorithm that will be developed based on the results. | 1 day | 
| Apnea/hypopnea index severity | Evaluation of agreement between patient categorisation into apnea severity categories obtained by the homemonitoring system and the diagnostic polysomnography scoring | 1 day |