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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: AL539 (SRETT)

• Registration Number: NCT01441622
• Lead Sponsor: Air Liquide Santé International

Brief Summary

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

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-27
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-27
• Last Update Posted: 2014-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AL539	AL539 (SRETT)	Device AL539

Primary Outcome Measures

Name	Time	Method
CPAP treatment duration	up to 12 hours	Continous Positive Airway Pressure treatment duration

Secondary Outcome Measures

Name	Time	Method
Apneas-Hypopneas	up to 12 hours	Apneas-Hypopneas Index (AHI) and Apneas Index (AI)
Mean pressure	up to 12 hours	Mean pressure in patient circuit
Mean Flow	up to 12 hours	Mean flow rate in patient circuit

Trial Locations

Locations (1)

Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance; 🇫🇷 Paris, France