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

Air Liquide

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: AL539 (SRETT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01441622

IDR CB / 2010-A00923-36 (Other Identifier)

ALMED-10-MD-030

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

AL539

Experimental group

Description:

Device AL539

Treatment:

Device: AL539 (SRETT)