Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: AL539 (SRETT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sleep apnea predominantly obstructive CPAP for at least 2 months and requiring in-hospital night polygraphic record Written informed consent form Able to read and write in French Exclusion Criteria: Ventilator with two levels of pressure CPAP breathing circuit non-compatible with the AL539 Chronic respiratory disease Psychotropic treatment which may influence the respiratory parameters Acute rhinitis or acute nasopharyngitis Moderate or severe chronic heart failure CHEYNE-STOKES respiration Body mass index (BMI) > 40 Pregnant woman or woman of childbearing potential with a positive urinary pregnancy test Uncontrolled progressive disease Psychiatric disorders or regular user of drugs Participation in any interventional clinical trial within 30 days prior to selection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL539<br>Device AL539 | Device: AL539 (SRETT)<br>* recording data with AL539 (SRETT)<br>* Other names: Manufacturer name : SRETT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP treatment duration | Continous Positive Airway Pressure treatment duration | up to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apneas-Hypopneas | Apneas-Hypopneas Index (AHI) and Apneas Index (AI) | up to 12 hours | 
| Mean pressure | Mean pressure in patient circuit | up to 12 hours | 
| Mean Flow | Mean flow rate in patient circuit | up to 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous Positive Airway Pressure (CPAP), AL539, Home-monitoring