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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01135303
Acronym
VISTAO2
Enrollment
182
Registered
2010-06-02
Start date
2009-02-28
Completion date
2011-01-31
Last updated
2011-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

Keywords

Sleep Apnea Syndromes, Polysomnography, Holter ECG, Thoracic impedance, Heart rate variability

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.

Interventions

DEVICEVistaO2 device

Full night VistaO2 device monitoring synchronized with the gold standard polysomnography.

Sponsors

Novacor
CollaboratorUNKNOWN
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* sleep apnea hypopnea syndrome suspicion * written consent

Exclusion criteria

* pacemaker * diabetes * atrial fibrillation * electrode allergy

Design outcomes

Primary

MeasureTime frameDescription
Sleep apnea hypopnea syndromeDay 1Apnea hypopnea index higher than 15, evaluated by polysomnography.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026