OSA Homemonitoring

Obstructive Sleep Apnea Clinical Trial

— OSA+  

Official title:

OSA Homemonitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03213236
• Other study ID #: S60319
• Status: Recruiting
• Phase: N/A
• First received: June 27, 2017
• Last updated: July 10, 2017
• Start date: July 2017
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Dries Testelmans, MD, PhD
• Phone: 00 32 16 342522
• Email: dries.testelmans[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Homemonitoring diagnostic system
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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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