Effectiveness of VistaO2 FLUX Device in Screening of Sleep Apnea/Hypopnea Syndrome (VISTAO2_FLUX)

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

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.

Study Overview

• Status: Terminated
• Conditions: Sleep Apnea Syndromes
• Intervention / Treatment: Device: VistaO2 FLUX device

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 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
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75000
    • Hopital Pitié Salpetriere - APHP
  • Saint-etienne, France, 42055
    • CHU DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• sleep apnea hypopnea syndrome suspicion
• written consent

Exclusion Criteria:

• pacemaker
• diabetes
• atrial fibrillation
• electrode allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: VistaO2 FLUX : ECG Holter recorder (Novacor, Rueil-Malmaison, France).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep apnea hypopnea syndrome	Apnea hypopnea index higher than 15, evaluated by polysomnography.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Novacor

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2015
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): June 2, 2017

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 6, 2015

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Polysomnography; Sleep Apnea Syndromes; Heart rate variability; Thoracic impedance; Holter ECG; Nasal flow
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: 1308191; 2014-A01733-44 (Other Identifier: AFSSAPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No