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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02357719
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : January 30, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Device: VistaO2 FLUX device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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 Name: VistaO2 FLUX : ECG Holter recorder (Novacor, Rueil-Malmaison, France).

Primary Outcome Measures :
  1. Sleep apnea hypopnea syndrome [ Time Frame: Day 1 ]
    Apnea hypopnea index higher than 15, evaluated by polysomnography.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • sleep apnea hypopnea syndrome suspicion
  • written consent

Exclusion Criteria:

  • pacemaker
  • diabetes
  • atrial fibrillation
  • electrode allergy

Information from the National Library of Medicine

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 identifier (NCT number): NCT02357719

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Contact: Frédéric ROCHE, MD PhD +33(0)477828300
Contact: Sébastien CELLE, PhD +33(0)477828300

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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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
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Principal Investigator: Frédéric ROCHE, MD-PhD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT02357719     History of Changes
Other Study ID Numbers: 1308191
2014-A01733-44 ( Other Identifier: AFSSAPS )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Sleep Apnea Syndromes
Holter ECG
Thoracic impedance
Heart rate variability
Nasal flow

Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases