Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome (AL539)
Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with Obstructive Sleep Apnea Syndrome (OSAS).
The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during attended in-hospital polysomnography in patients with Obstructive Sleep Apnea Syndrome.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||In-hospital Assessment of the New Medical Device AL539 Developed for the Home Monitoring of Continuous Positive Airway Pressure (CPAP) Treatment in Patients With Obstructive Sleep Apnea Syndrome by Comparison With Respiratory Polygraphy|
- CPAP treatment duration [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]Continous Positive Airway Pressure treatment duration
- Apneas-Hypopneas [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]Apneas-Hypopneas Index (AHI) and Apneas Index (AI)
- Mean pressure [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]Mean pressure in patient circuit
- Mean Flow [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]Mean flow rate in patient circuit
|Study Start Date:||June 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Device: AL539 (SRETT)
recording data with AL539 (SRETT)
Other Name: Manufacturer name : SRETT
Patients are patients with sleep apnea predominantly obstructive, with CPAP for at least 2 months, and requiring in-hospital night polygraphic record control.
The medical device was developed to determine:
- the duration of use of CPAP by the patient,
- the persistence of any respiratory abnormalities during treatment.
These two parameters are used to ensure that treatment is done correctly.
The use of the AL539 is expected to improve the home-monitoring of ventilation with CPAP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441622
|Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance|
|Paris, France, 75181|
|Principal Investigator:||Damien LEGER, Pr||Hôpital Hôtel Dieu|