Study Stopped
Lack of inclusion
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
2 other identifiers
interventional
96
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
February 6, 2015
CompletedStudy Start
First participant enrolled
March 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2017
CompletedJuly 14, 2022
July 1, 2022
2.2 years
February 3, 2015
July 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep apnea hypopnea syndrome
Apnea hypopnea index higher than 15, evaluated by polysomnography.
Day 1
Study Arms (1)
VistaO2 FLUX device
EXPERIMENTALThis 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.
Interventions
Full night VistaO2 FLUX device monitoring synchronized with the gold standard polysomnography.
Eligibility Criteria
You may qualify if:
- sleep apnea hypopnea syndrome suspicion
- written consent
You may not qualify if:
- pacemaker
- diabetes
- atrial fibrillation
- electrode allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier Universitaire de Saint Etiennelead
- Novacorcollaborator
Study Sites (2)
Hopital Pitié Salpetrière - APHP
Paris, 75000, France
CHU de Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric ROCHE, MD-PhD
CHU de Saint-Etienne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2015
First Posted
February 6, 2015
Study Start
March 5, 2015
Primary Completion
May 31, 2017
Study Completion
June 2, 2017
Last Updated
July 14, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share