Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome (AL539)
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|ClinicalTrials.gov Identifier: NCT01441622|
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : June 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Syndrome||Device: AL539 (SRETT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Device: AL539 (SRETT)
recording data with AL539 (SRETT)
Other Name: Manufacturer name : SRETT
- CPAP treatment duration [ Time Frame: up to 12 hours ]Continous Positive Airway Pressure treatment duration
- Apneas-Hypopneas [ Time Frame: up to 12 hours ]Apneas-Hypopneas Index (AHI) and Apneas Index (AI)
- Mean pressure [ Time Frame: up to 12 hours ]Mean pressure in patient circuit
- Mean Flow [ Time Frame: up to 12 hours ]Mean flow rate in patient circuit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441622
|Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance|
|Paris, France, 75181|
|Principal Investigator:||Damien LEGER, Pr||Hôpital Hôtel Dieu|