Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome (VISTAO2)
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Paris, Frankrig, 75000
- Hôpital Tenon - APHP
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Saint-etienne, Frankrig, 42055
- CHU de Saint-Etienne
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- sleep apnea hypopnea syndrome suspicion
- written consent
Exclusion Criteria:
- pacemaker
- diabetes
- atrial fibrillation
- electrode allergy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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Full night VistaO2 device monitoring synchronized with the gold standard polysomnography.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Søvnapnø hypopnø syndrom
Tidsramme: Dag 1
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Apnø hypopnø-indeks højere end 15, vurderet ved polysomnografi.
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Dag 1
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 0808119
- 2008-A01530-55 (Anden identifikator: AFSSAPS)
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Kliniske forsøg med Søvnapnø syndromer
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University of Wisconsin, MadisonPhilips HealthcareAfsluttetSøvn, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
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Aventure ABAktiv, ikke rekrutterende
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National Taiwan University HospitalUkendt
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National University of SingaporeRekrutteringReduktion af skærmbrug + Sleep Extension | Frit levendeSingapore
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The First Affiliated Hospital of Shanxi Medical...Shanxi Medical UniversityAfsluttetSøvnkvalitet | Søvnvarighed | Sleep Onset LatencyKina
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Maastricht University Medical CenterEpilepsiecentrum KempenhaegheAfsluttetRolandsk Epilepsi | Landau-Kleffners syndrom | Natlig frontallappens epilepsi | Elektrisk status Epilepticus under Slow Wave SleepHolland
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Northwell HealthJazz PharmaceuticalsRekrutteringElektrisk status Epilepticus af Slow-Wave SleepForenede Stater
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Tyco Healthcare GroupUkendt
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University of Geneva, SwitzerlandAfsluttetNatlige benkramper | Sleep Wake Transition DisordersSchweiz
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Riphah International UniversityAfsluttet
Kliniske forsøg med VistaO2 device
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Centre Hospitalier Universitaire de Saint EtienneNovacorAfsluttetSøvnapnø syndromerFrankrig