Sleep Apnea SyndromesVISTAO2_FLUXNCT02357719
Effectiveness of VistaO2 FLUX Device in Screening of Sleep Apnea/Hypopnea Syndrome
A study testing VistaO2 FLUX device in people with Sleep Apnea Syndromes, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- VistaO2 FLUX device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Mar 2015to 2 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- sleep apnea hypopnea syndrome suspicion
- written consent
Who cannot join
- pacemaker
- diabetes
- atrial fibrillation
- electrode allergy
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Pitié Salpetrière - APHP
Paris, 75000
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome
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.
Read the 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.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- VistaO2 FLUX device
- Keywords
- Sleep Apnea Syndromes, Polysomnography, Holter ECG, Thoracic impedance, Heart rate variability, Nasal flow
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VistaO2 FLUX deviceDevice
Also called VistaO2 FLUX : ECG Holter recorder (Novacor, Rueil-Malmaison, France).
Full night VistaO2 FLUX device monitoring synchronized with the gold standard polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| VistaO2 FLUX device | Experimental | 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. Receives: Device: VistaO2 FLUX device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep apnea hypopnea syndrome
Apnea hypopnea index higher than 15, evaluated by polysomnography.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study start5 Mar 2015
- Primary completion31 May 2017
- Study completion2 Jun 2017
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Novacor
- Responsible party
- Sponsor
- Investigators
- Frédéric ROCHE, MD-PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357719
- Sponsor's protocol ID
- 1308191
- Other IDs
- 2014-A01733-44
- Acronym
- VISTAO2_FLUX
- Status last verified
- Jul 2022
- First submitted
- 3 Feb 2015
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT02357719
- Acronym / sponsor ID
- VISTAO2_FLUX / 1308191
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea Syndromes, Polysomnography, Holter ECG, Thoracic impedance, Heart rate variability, Nasal flow
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Novacor
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 2 Jun 2017 (actual)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VistaO2 FLUX device | Experimental | Device: VistaO2 FLUX deviceThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- sleep apnea hypopnea syndrome suspicion
- written consent
Key exclusion criteria (4 listed)
- pacemaker
- diabetes
- atrial fibrillation
- electrode allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VistaO2 FLUX deviceAlso: VistaO2 FLUX : ECG Holter recorder (Novacor, Rueil-Malmaison, France).Full night VistaO2 FLUX device monitoring synchronized with the gold standard polysomnography. | Device | VistaO2 FLUX device |
Primary outcome
Sleep apnea hypopnea syndrome
Time frame: Day 1
Apnea hypopnea index higher than 15, evaluated by polysomnography.
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Individual participant dataSharing planned: No
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Comprehensive Opioid Management and Breathing During Sleep
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Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric ROCHE, MD-PhD principal investigator
CHU de Saint-Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VistaO2 FLUX device in people with Sleep Apnea Syndromes, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep apnea hypopnea syndrome (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.