Effectiveness of VistaO2 FLUX Device in Screening of Sleep Apnea/Hypopnea Syndrome (VISTAO2_FLUX)
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|ClinicalTrials.gov Identifier: NCT02357719|
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : January 30, 2019
The high prevalence (9% in men and 4% in women) of sleep apnea / hypopnea syndrome (SAHS) in adults is now well documented as well as its cardiovascular repercussions. Previous studies showed a conclusive link between SAHS and severe cardiovascular diseases such as hypertension, myocardial infarction, heart failure and stroke.Then, SAHS is a public health issue in adults.
In this context, early detection of such a disease is crucial if the management is tailored to the patient, the practitioner's choice of therapy moving towards continuous positive airway pressure (CPAP) or mandibular advancement device. The detection is based on full nocturnal polysomnography or polygraphic recordings. Polysomnography remains the gold standard but it is a time consuming and costly examination. Polygraphic recording is a test that allows simplified the diagnosis of severe patients, but may not be sufficient for mild form of SAHS. Thus, the SAHS is a pathology under-diagnosed and under-treated. The validation of a technique for identifying patients most at risk to either limit the number of polysomnographic examination is requested.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndromes||Device: VistaO2 FLUX device||Not Applicable|
In this perspective, the development of a product screening sleep related breathing disorders for physicians, cardiologists, internists (not specialized sleep experts) would fill this need. It allows for a reliable first screening for their patients in parallel with a routine cardiological examination. Imposing a minimal human and material, the ECG Holter recorder "VistaO2 FLUX" (NOVACOR, Rueil-Malmaison, France) is a device designed to meet these requirements. This device fits into the daily management of patients with cardiac arrhythmias or sinus/atrioventricular conduction disorders, and of patients suffering myocardial infarction (arrhythmic risk stratification, detection of silent myocardial ischemia).
Analysis of heart rate variability (HRV) has already shown interest in screening SAHS. We therefore wish to evaluate the performance of the analysis of data from the screening tool VistaO2 FLUX face what the gold standard synchronized polysomnography.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome|
|Actual Study Start Date :||March 5, 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: VistaO2 FLUX device
This device combines the transcutaneous oxyhemoglobin saturation (allowing to compute the oxyhemoglobin desaturation index), the slow variations in heart rate, the nasal flow and an index of nocturnal respiratory events calculated by analyzing the movements of the chest performed by chest impedance variations.
Device: VistaO2 FLUX device
Full night VistaO2 FLUX device monitoring synchronized with the gold standard polysomnography.
Other Name: VistaO2 FLUX : ECG Holter recorder (Novacor, Rueil-Malmaison, France).
- Sleep apnea hypopnea syndrome [ Time Frame: Day 1 ]Apnea hypopnea index higher than 15, evaluated by polysomnography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357719
|Contact: Frédéric ROCHE, MD PhD||+33(0)firstname.lastname@example.org|
|Contact: Sébastien CELLE, PhD||+33(0)email@example.com|
|Hopital Pitié Salpetrière - APHP||Recruiting|
|Paris, France, 75000|
|Principal Investigator: Carole PHILIPPE, MD|
|CHU de Saint-Etienne||Recruiting|
|Saint-etienne, France, 42055|
|Principal Investigator: Frédéric ROCHE, MD-PhD|
|Sub-Investigator: Isabelle COURT-FORTUNE, MD|
|Sub-Investigator: Jean-Claude BARTHELEMY, MD-PhD|
|Principal Investigator:||Frédéric ROCHE, MD-PhD||CHU de Saint-Etienne|