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

Sleep Apnea Syndromes Clinical Trial

— VISTAO2_FLUX  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02357719
• Other study ID #: 1308191
• Secondary ID: 2014-A01733-44
• Status: Terminated
• Phase: N/A
• Start date: March 5, 2015
• Est. completion date: June 2, 2017

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 96
• Est. completion date: June 2, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• sleep apnea hypopnea syndrome suspicion

• written consent

Exclusion Criteria:

• pacemaker

• diabetes

• atrial fibrillation

• electrode allergy

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• VistaO2 FLUX device
Full night VistaO2 FLUX device monitoring synchronized with the gold standard polysomnography.

Locations

Country	Name	City	State
France	Hopital Pitié Salpetrière - APHP	Paris
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Novacor

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep apnea hypopnea syndrome	Apnea hypopnea index higher than 15, evaluated by polysomnography.	Day 1