Sleep ApneaPhase 4AIRLESSNCT02045173
Automate Detection of Sleep Apnea by ApneascanTM
A Phase 4 study testing Apneascan TM and Polysomnography/polygraphy in people with Sleep Apnea and Arrhythmias, run by University Hospital, Grenoble at 5 sites in France.
Trial summary
The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Arrhythmias
- What is being tested?
- Apneascan TM and Polysomnography/polygraphy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2014to Oct 2016
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female aged > 18 years old
- Current ICD or CRT-D device-based guidelines indication (for primo-implantation)
- patients with optimal recommended medical therapy
- Patient willing and able of undergoing the device implant procedure
- Patient willing and able of undergoing the LATITUDE® NXT Patient Management system procedure
- Patient willing and able to complete the requirements of the study including the signature of the Informed Consent after full explanation of the study by the investigator prior to participation.
Who cannot join
- Obstructive lung disease as defined by a FEV1/FVC less than 70%
- Obesity hypoventilation syndrome
- Treated sleep disorders breathing
- Cardiac surgery scheduled or strong likelihood of cardiac surgery 4 months after enrollment
- Life expectancy less than 1 year
- Inability to complete overnight PSG as defined by the protocol
Show all 9Show fewer
- Patient who are or suspected to be pregnant and or plan to become pregnant
- Patient protected by the Law, under guardianship or curators
- Concomitant participation in an interventional biomedical research trial
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Grenoble
Grenoble
Hôpital Arnaud de Villeneuve
Montpellier
Hopital Barbois
Nancy
Clinique Pasteur
Toulouse
Hôpital Trousseau
Tours
About this study
Official title: Screening for Sleep-disordered Breathing in Routine Cardiology Practice: Validation of the Apnea + Hypopnea Detection by an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-defibrillator (CRT-D) With Impedance-based Respiration Sensor (ApneaScanTM)
The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable impedance-based respiration sensor (AHIAS).
Read the detailed description
This is a prospective, multi center, phase-IV with blinded analysis and central reading of polysomnography trial.
The study is performed in patients with a standard CRT-D or Implantable Cardioverter Defibrillator (ICD) devices indication. A total of 160 subjects will be recruited in France. The study duration is 03 months for each subject.
- Conditions
- Sleep Apnea, Arrhythmias
- Being tested
- Apneascan TM, Polysomnography/polygraphy
- Keywords
- Sleep apnea, Arrhythmias, Heart Failure, ICD, CRT-D, Apneascan
- Medical subject headings
- Sleep Apnea Syndromes, Arrhythmias, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneascan TMOther
Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM
Polysomnography/polygraphyDevice
1 night polysomnography/polygraphy
| Study group | Role | What they receive |
|---|---|---|
| Apneascan TM | Other | autoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy Receives: Other: Apneascan TM; Device: Polysomnography/polygraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor
Measured: Prior the ICD or CRT-D implantation and up to 3 months
Secondary outcomes (3)
Malignant arrhythmogenic events detected daily by the ICD / CRT-D (AF, ES, supraventricular tachycardia, sustained and non sustained ventricular tachycardia, VF) and night by night AHI assessed by the ApneascanTM
Measured: baseline and up to 3 months
Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)
Measured: Baseline and Up to 3 months
Apnea and Hypopnea index measured 3 months after ICR or CRT-D implantation compared to the Apnea and Hypopnea index measured at baseline by the polysomnography or polygraphy
Measured: Prior the ICD or CRT-D implantation and up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Louis PEPIN, MD, PhD, Principal investigator, Grenoble Hospital UniversityPascal DEFAYE, MD, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045173
- Sponsor's protocol ID
- 1332
- Acronym
- AIRLESS
- Status last verified
- Oct 2016
- First submitted
- 22 Jan 2014
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Sleep-disordered Breathing in Routine Cardiology Practice: Validation of the Apnea + Hypopnea Detection by an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-defibrillator (CRT-D) With Impedance-based Respiration Sensor (ApneaScanTM)
- ClinicalTrials.gov ID
- NCT02045173
- Acronym / sponsor ID
- AIRLESS / 1332
- Conditions
- Sleep Apnea, Arrhythmias
- Keywords
- Sleep apnea, Arrhythmias, Heart Failure, ICD, CRT-D, Apneascan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 24 Jan 2014 (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 purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable impedance-based respiration sensor (AHIAS).
Detailed description
This is a prospective, multi center, phase-IV with blinded analysis and central reading of polysomnography trial.
The study is performed in patients with a standard CRT-D or Implantable Cardioverter Defibrillator (ICD) devices indication. A total of 160 subjects will be recruited in France. The study duration is 03 months for each subject.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apneascan TM | Other | Other: Apneascan TM, Device: Polysomnography/polygraphyautoscoring algorithms of the Apneascan TM compared to the polysomnography or polygraphy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female aged > 18 years old
- Current ICD or CRT-D device-based guidelines indication (for primo-implantation)
- patients with optimal recommended medical therapy
- Patient willing and able of undergoing the device implant procedure
- Patient willing and able of undergoing the LATITUDE® NXT Patient Management system procedure
Key exclusion criteria (9 listed)
- Obstructive lung disease as defined by a FEV1/FVC less than 70%
- Obesity hypoventilation syndrome
- Treated sleep disorders breathing
- Cardiac surgery scheduled or strong likelihood of cardiac surgery 4 months after enrollment
- Life expectancy less than 1 year
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 |
|---|---|---|
| Apneascan TMAutoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM | Other | Apneascan TM |
| Polysomnography/polygraphy1 night polysomnography/polygraphy | Device | Apneascan TM |
Primary outcome
Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor
Time frame: Prior the ICD or CRT-D implantation and up to 3 months
3 secondary outcomes
Malignant arrhythmogenic events detected daily by the ICD / CRT-D (AF, ES, supraventricular tachycardia, sustained and non sustained ventricular tachycardia, VF) and night by night AHI assessed by the ApneascanTM
Time frame: baseline and up to 3 months
Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)
Time frame: Baseline and Up to 3 months
Apnea and Hypopnea index measured 3 months after ICR or CRT-D implantation compared to the Apnea and Hypopnea index measured at baseline by the polysomnography or polygraphy
Time frame: Prior the ICD or CRT-D implantation and up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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.
Jean Louis PEPIN, MD, PhD principal investigator
Grenoble Hospital University
Pascal DEFAYE, MD principal investigator
Grenoble Hospital University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apneascan TM and Polysomnography/polygraphy in people with Sleep Apnea and Arrhythmias, run by University Hospital, Grenoble at 5 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 6 inclusion and 9 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: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor (time frame: Prior the ICD or CRT-D implantation and up to 3 months). 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 21 Oct 2016.