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OSA Homemonitoring (OSA+)

U

Universitaire Ziekenhuizen KU Leuven

Status

Withdrawn

Conditions

Obstructive Sleep Apnea

Treatments

Diagnostic Test: Homemonitoring diagnostic system

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

OSA Homemonitoring
Experimental group
Description:
Homemonitoring diagnostic system
Treatment:
Diagnostic Test: Homemonitoring diagnostic system

Trial contacts and locations

1

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Central trial contact

Dries Testelmans, MD, PhD

Data sourced from clinicaltrials.gov

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