Chronic Heart Failure andOTRLASVNCT02429986
Adaptive Servo-Ventilation in "Real Life" Conditions : the OTRLASV Study
A study testing Adaptive Servo-Ventilation in people with Chronic Heart Failure and and Complex Sleep Apnea Syndrome, run by University Hospital, Montpellier at 5 sites in France.
Trial summary
Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure and, Complex Sleep Apnea Syndrome, Obstructive Sleep Apnea Syndrome and
- What is being tested?
- Adaptive Servo-Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 5 sitesFrance
- Study dates
- 13 Mar 2015to 17 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age more than 18 years (inclusive)
- Patient treated with ASV for at least one year,and eligible for care and for the reimbursement by the French Social Security rules.
- Patient presenting at the annual control consultation for the continuation of the ASV treatment according to the French Social Security rules.
Who cannot join
- Pregnancy, intention of being pregnant, breastfeeding.
- Inability to understand the nature and aims of the study or to communicate with the investigator
- Simultaneous participation in another trial with an exclusion clause to participate to an other trial.
- No affiliation to the French social security
- Loss of personal capacity resulting in state protection
- Deprivation of liberty by judicial or administrative decision
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Polyclinic Saint-Privat
Boujan-sur-Libron, 34480
CHU Dijon
Dijon, 21079
Hôpital Nord
Marseille, 13015
Arnaud de Villeneuve University Hospital
Montpellier, 34295
Hôpital Pitié Salpetrière
Paris, 75651
About this study
Official title: Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation
Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the investigators aim to describe the clinical characteristics of patients treated with ASV and the associated device settings.
Read the detailed description
The purpose of this study is to evaluate in "real life conditions" the use of Adaptative Servo-Ventilation (ASV) treatment. ASV treatment is routinely prescribed in France in patients with various sleep disorders breathing (Chronic Heart Failure (CHF) and Central Sleep Apnea Syndrome (CSAS), CHF and central and obstructive sleep apnea (COSA), Obstructive Sleep Apnea Syndrome (OSAS) and complex sleep apnea syndrome (compSAS), idiopathic or drug induced periodic breathing.
In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the aim is to describe the clinical characteristics of patients treated with ASV and the associated device settings. The aim is to evaluate the safety and efficacy issues in real life conditions of the ASV prescription.Depending of the data, data are obtained after analysis of the six latest months data of the ASV device, after questioning the patient, after analysis of the polygraphy/oximetry (if prescribed by the doctor for the renewal consultation of the ASV care and reimbursement by the French Social Security). All the data are obtained during the annual consultation required by the French Social Security.
- Conditions
- Chronic Heart Failure and, Complex Sleep Apnea Syndrome, Obstructive Sleep Apnea Syndrome and, Idiopathic Central Sleep Apnea Syndrome, Idiopathic Induced Periodic Breathing, Central Sleep Apnea Syndrome
- Being tested
- Adaptive Servo-Ventilation
- Keywords
- Adaptive Servo-Ventilation, Chronic Heart Failure, Central Sleep Apnea Syndrome, Central and Obstructive Sleep Apnea Syndrome, Complex Sleep Apnea Syndrome, Hunter-Cheyne-Stokes Breathing, Periodic Breathing
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Servo-VentilationDevice
Adaptive Servo-Ventilation proceeds by continually measuring either minute ventilation or airflow and calculates a target ventilation to be applied as needed.
| Study group | Role | What they receive |
|---|---|---|
| ASV Arm | Other | The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care. Receives: Device: Adaptive Servo-Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings
Relationship between the residual AHI and the associated pressure settings, in function of the phenotype of the patients (presence or absence of cardiopathy, presence or absence of altered left ventricular ejection fraction (≤45% or > 45%)
Measured: The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care. The measures are obtained after analysis of the six latest months data of the device.
Secondary outcomes (13)
Sleep Disorder Breathing involved in the initial prescription of ASV
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion
ASV compliance (number of hour per day, number of day with ≥3 hours in the past 6 months)
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Type of device used nad history of device used (CPAP used before ASV ?)
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security)
Measured: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Used or not of an auto-EPAP
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Settings of the device (Inspiratory and Expiratory pressures, duration of pressurization, backup frequency)
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Type of mask used and historical use of mask
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Changes in AHI as compared to baseline
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline if available
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion
Changes in Asthenia by measuring Pichot scale as compared to baseline if available
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion
Number of hospitalization during the last year and etiology of the hospitalization
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion
Presence of a cardiomyopathy
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion
Treatment of the cardiomyopathy (medication consumption and use of cardiac implant will be reported)
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: The day of inclusion
Number of patients not showing up for the annual consultation
The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).
Measured: One year after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study start13 Mar 2015
- Primary completion17 Jan 2017
- Study completion17 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart Failure andStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dany JAFFUEL, MD, PhD, Principal investigator, Polyclinic Saint-Privat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429986
- Sponsor's protocol ID
- 9498
- Other IDs
- 2014-A01565-42
- Acronym
- OTRLASV
- Status last verified
- Sep 2020
- First submitted
- 1 Apr 2015
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Jaffuel D, Philippe C, Rabec C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. What is the remaining status of adaptive servo-ventilation? The results of a real-life multicenter study (OTRLASV-study) : Adaptive servo-ventilation in real-life conditions. Respir Res. 2019 Oct 29;20(1):235. doi: 10.1186/s12931-019-1221-9.
PubMed 31665026Jaffuel D, Rabec C, Philippe C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. Patterns of adaptive servo-ventilation settings in a real-life multicenter study: pay attention to volume! : Adaptive servo-ventilation settings in real-life conditions. Respir Res. 2020 Sep 21;21(1):243. doi: 10.1186/s12931-020-01509-7.
PubMed 32957983Jaffuel D, Mallet JP, Combes N, Palot A, Rabec C, Molinari N, Jaber S, Bourdin A. [Adaptive servo-ventilation after the SERVE-HF study: The swan song?]. Rev Mal Respir. 2016 Sep;33(7):641-4. doi: 10.1016/j.rmr.2016.04.001. Epub 2016 May 5. No abstract available. French.
PubMed 27155898
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation
- ClinicalTrials.gov ID
- NCT02429986
- Acronym / sponsor ID
- OTRLASV / 9498
- Conditions
- Chronic Heart Failure and, Complex Sleep Apnea Syndrome, Obstructive Sleep Apnea Syndrome and, Idiopathic Central Sleep Apnea Syndrome, Idiopathic Induced Periodic Breathing, Central Sleep Apnea Syndrome
- Keywords
- Adaptive Servo-Ventilation, Chronic Heart Failure, Central Sleep Apnea Syndrome, Central and Obstructive Sleep Apnea Syndrome, Complex Sleep Apnea Syndrome, Hunter-Cheyne-Stokes Breathing, Periodic Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 Mar 2015 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 17 Jan 2017 (actual)
- First posted
- 29 Apr 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.
Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the investigators aim to describe the clinical characteristics of patients treated with ASV and the associated device settings.
Detailed description
The purpose of this study is to evaluate in "real life conditions" the use of Adaptative Servo-Ventilation (ASV) treatment. ASV treatment is routinely prescribed in France in patients with various sleep disorders breathing (Chronic Heart Failure (CHF) and Central Sleep Apnea Syndrome (CSAS), CHF and central and obstructive sleep apnea (COSA), Obstructive Sleep Apnea Syndrome (OSAS) and complex sleep apnea syndrome (compSAS), idiopathic or drug induced periodic breathing.
In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the aim is to describe the clinical characteristics of patients treated with ASV and the associated device settings. The aim is to evaluate the safety and efficacy issues in real life conditions of the ASV prescription.Depending of the data, data are obtained after analysis of the six latest months data of the ASV device, after questioning the patient, after analysis of the polygraphy/oximetry (if prescribed by the doctor for the renewal consultation of the ASV care and reimbursement by the French Social Security). All the data are obtained during the annual consultation required by the French Social Security.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASV Arm | Other | Device: Adaptive Servo-VentilationThe measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Age more than 18 years (inclusive)
- Patient treated with ASV for at least one year,and eligible for care and for the reimbursement by the French Social Security rules.
- Patient presenting at the annual control consultation for the continuation of the ASV treatment according to the French Social Security rules.
Key exclusion criteria (6 listed)
- Pregnancy, intention of being pregnant, breastfeeding.
- Inability to understand the nature and aims of the study or to communicate with the investigator
- Simultaneous participation in another trial with an exclusion clause to participate to an other trial.
- No affiliation to the French social security
- Loss of personal capacity resulting in state protection
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 |
|---|---|---|
| Adaptive Servo-VentilationAdaptive Servo-Ventilation proceeds by continually measuring either minute ventilation or airflow and calculates a target ventilation to be applied as needed. | Device | ASV Arm |
Primary outcome
Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings
Time frame: The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care. The measures are obtained after analysis of the six latest months data of the device.
Relationship between the residual AHI and the associated pressure settings, in function of the phenotype of the patients (presence or absence of cardiopathy, presence or absence of altered left ventricular ejection fraction (≤45% or > 45%)
13 secondary outcomes
Sleep Disorder Breathing involved in the initial prescription of ASV
Time frame: The day of inclusion
ASV compliance (number of hour per day, number of day with ≥3 hours in the past 6 months)
Time frame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Type of device used nad history of device used (CPAP used before ASV ?)
Time frame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Used or not of an auto-EPAP
Time frame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Settings of the device (Inspiratory and Expiratory pressures, duration of pressurization, backup frequency)
Time frame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Type of mask used and historical use of mask
Time frame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Changes in AHI as compared to baseline
Time frame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline if available
Time frame: The day of inclusion
Changes in Asthenia by measuring Pichot scale as compared to baseline if available
Time frame: The day of inclusion
Number of hospitalization during the last year and etiology of the hospitalization
Time frame: The day of inclusion
Presence of a cardiomyopathy
Time frame: The day of inclusion
Treatment of the cardiomyopathy (medication consumption and use of cardiac implant will be reported)
Time frame: The day of inclusion
Number of patients not showing up for the annual consultation
Time frame: One year after the start of the study
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 25 Sep 2020.
- Results publication: PubMed 31665026Jaffuel D, Philippe C, Rabec C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. What is the remaining status of adaptive servo-ventilation? The results of a real-life multicenter study (OTRLASV-study) : Adaptive servo-ventilation in real-life conditions. Respir Res. 2019 Oct 29;20(1):235. doi: 10.1186/s12931-019-1221-9.
- Results publication: PubMed 32957983Jaffuel D, Rabec C, Philippe C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. Patterns of adaptive servo-ventilation settings in a real-life multicenter study: pay attention to volume! : Adaptive servo-ventilation settings in real-life conditions. Respir Res. 2020 Sep 21;21(1):243. doi: 10.1186/s12931-020-01509-7.
- Results publication: PubMed 27155898Jaffuel D, Mallet JP, Combes N, Palot A, Rabec C, Molinari N, Jaber S, Bourdin A. [Adaptive servo-ventilation after the SERVE-HF study: The swan song?]. Rev Mal Respir. 2016 Sep;33(7):641-4. doi: 10.1016/j.rmr.2016.04.001. Epub 2016 May 5. No abstract available. French.
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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.
Dany JAFFUEL, MD, PhD principal investigator
Polyclinic Saint-Privat
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Servo-Ventilation in people with Chronic Heart Failure and and Complex Sleep Apnea Syndrome, run by University Hospital, Montpellier 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 4 inclusion and 6 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 25 Sep 2020. 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.
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?
Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings (time frame: The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care. The measures are obtained after analysis of the six latest months data of the device.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02429986, which also lists 3 linked publications.
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 25 Sep 2020.