OSA Homemonitoring

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Diagnostic Test: Homemonitoring diagnostic system

• Registration Number: NCT03213236
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-27
• Study Start: 2017-07-01
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Primary Completion: 2020-09-28
• Study Completion: 2020-09-28
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OSA Homemonitoring	Homemonitoring diagnostic system	Homemonitoring diagnostic system

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the homemonitoring system	1 day	Accuracy of the homemonitoring system of apnea/hypopnea index measurement (in comparison with gold standard) polysomnography)

Secondary Outcome Measures

Name	Time	Method
Apnea/hypopnea index severity	1 day	Evaluation of agreement between patient categorisation into apnea severity categories obtained by the homemonitoring system and the diagnostic polysomnography scoring
Cardiovascular risk prediction tool	1 day	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.

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium