Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Device: VistaO2 device

• Registration Number: NCT01135303
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

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" (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 face what the gold standard synchronized polysomnography.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-31
• Study First Posted: 2010-06-02
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-20
• Last Update Posted: 2011-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• sleep apnea hypopnea syndrome suspicion
• written consent

Exclusion Criteria

• pacemaker
• diabetes
• atrial fibrillation
• electrode allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VistaO2 device	VistaO2 device	This device combines the transcutaneous oxyhemoglobin saturation (allowing to compute the oxyhemoglobin desaturation index), the slow variations in heart rate and an index of nocturnal respiratory events calculated by analyzing the movements of the chest performed by chest impedance variations.

Primary Outcome Measures

Name	Time	Method
Sleep apnea hypopnea syndrome	Day 1	Apnea hypopnea index higher than 15, evaluated by polysomnography.

Trial Locations

Locations (2)

Hôpital TENON - APHP; 🇫🇷 Paris, France

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France