NCT01441622

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Air Liquide Santé International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DEVICE	AL539 (SRETT)	recording data with AL539 (SRETT)

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-09-27
• Last updated: 2014-06-30

Locations

1 site across 1 country: France