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Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome (VISTAO2)

This study has been completed.
Sponsor:
Collaborator:
Novacor
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT01135303
First received: May 25, 2010
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Sleep Apnea Syndromes
 Device: VistaO2 device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Sleep apnea hypopnea syndrome [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Apnea hypopnea index higher than 15, evaluated by polysomnography.


Enrollment: 182
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Device: VistaO2 device
Full night VistaO2 device monitoring synchronized with the gold standard polysomnography.
Other Name: VistaO2 : ECG Holter recorder (Novacor, Rueil-Malmaison, France).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • sleep apnea hypopnea syndrome suspicion
  • written consent

Exclusion Criteria:

  • pacemaker
  • diabetes
  • atrial fibrillation
  • electrode allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01135303

Locations
France
Hôpital TENON - APHP
Paris, France, 75000
CHU de Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Novacor
Investigators
Principal Investigator: Frédéric ROCHE, MD-PhD CHU de Saint-Etienne
  More Information

No publications provided by Centre Hospitalier Universitaire de Saint Etienne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clément CAILLAUX, Centre Hospitalier Universitaire de Saint-Etienne
ClinicalTrials.gov Identifier: NCT01135303     History of Changes
Other Study ID Numbers: 0808119, 2008-A01530-55
Study First Received: May 25, 2010
Last Updated: July 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

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

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

ClinicalTrials.gov processed this record on May 16, 2013