Effectiveness of VistaO2 FLUX Device in Screening of Sleep Apnea/Hypopnea Syndrome (VISTAO2_FLUX)
Primary Purpose
Sleep Apnea Syndromes
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
VistaO2 FLUX device
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea Syndromes focused on measuring Sleep Apnea Syndromes, Polysomnography, Holter ECG, Thoracic impedance, Heart rate variability, Nasal flow
Eligibility Criteria
Inclusion Criteria:
- sleep apnea hypopnea syndrome suspicion
- written consent
Exclusion Criteria:
- pacemaker
- diabetes
- atrial fibrillation
- electrode allergy
Sites / Locations
- Hopital Pitié Salpetrière - APHP
- CHU de Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VistaO2 FLUX device
Arm Description
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.
Outcomes
Primary Outcome Measures
Sleep apnea hypopnea syndrome
Apnea hypopnea index higher than 15, evaluated by polysomnography.
Secondary Outcome Measures
Full Information
NCT ID
NCT02357719
First Posted
February 3, 2015
Last Updated
July 13, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Novacor
1. Study Identification
Unique Protocol Identification Number
NCT02357719
Brief Title
Effectiveness of VistaO2 FLUX Device in Screening of Sleep Apnea/Hypopnea Syndrome
Acronym
VISTAO2_FLUX
Official Title
Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of inclusion
Study Start Date
March 5, 2015 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
June 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Novacor
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Sleep Apnea Syndromes, Polysomnography, Holter ECG, Thoracic impedance, Heart rate variability, Nasal flow
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VistaO2 FLUX device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
VistaO2 FLUX device
Other Intervention Name(s)
VistaO2 FLUX : ECG Holter recorder (Novacor, Rueil-Malmaison, France).
Intervention Description
Full night VistaO2 FLUX device monitoring synchronized with the gold standard polysomnography.
Primary Outcome Measure Information:
Title
Sleep apnea hypopnea syndrome
Description
Apnea hypopnea index higher than 15, evaluated by polysomnography.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
sleep apnea hypopnea syndrome suspicion
written consent
Exclusion Criteria:
pacemaker
diabetes
atrial fibrillation
electrode allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ROCHE, MD-PhD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Pitié Salpetrière - APHP
City
Paris
ZIP/Postal Code
75000
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of VistaO2 FLUX Device in Screening of Sleep Apnea/Hypopnea Syndrome
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