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

Air Liquide Santé International20 enrolled

Overview

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.

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

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

AL539 (SRETT)DEVICE

recording data with AL539 (SRETT)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance

Paris, France

Outcomes

Primary Outcomes

CPAP treatment duration

Continous Positive Airway Pressure treatment duration

Time frame: up to 12 hours

Secondary Outcomes

Apneas-Hypopneas

Apneas-Hypopneas Index (AHI) and Apneas Index (AI)

Time frame: up to 12 hours

Mean pressure

Mean pressure in patient circuit

Time frame: up to 12 hours

Mean Flow

Mean flow rate in patient circuit

Time frame: up to 12 hours

Data from ClinicalTrials.gov

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