Complex Sleep Apnea Syndrome Clinical Trial
— OTRLASVOfficial title:
Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation
| Verified date | September 2020 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 214 |
| Est. completion date | January 17, 2017 |
| Est. primary completion date | January 17, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Polyclinic Saint-Privat | Boujan sur Libron | |
| France | CHU Dijon | Dijon | |
| France | Hôpital Nord | Marseille | |
| France | Arnaud de Villeneuve University Hospital | Montpellier | |
| France | Hôpital Pitié Salpetrière | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
Jaffuel 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. French. — View Citation
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-v — View Citation
Jaffuel 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 set — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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%) | 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 | 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). | The day of inclusion | |
| Secondary | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | |
| Secondary | 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) | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | |
| Secondary | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | |
| Secondary | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | |
| Secondary | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | |
| Secondary | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | |
| Secondary | 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). | The day of inclusion | |
| Secondary | 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). | The day of inclusion | |
| Secondary | 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). | The day of inclusion | |
| Secondary | 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). | The day of inclusion | |
| Secondary | 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). | The day of inclusion | |
| Secondary | 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). | One year after the start of the study |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00915499 -
Complex Sleep Apnea Syndrome (CompSAS) Resolution Study
|
N/A |