Status:
COMPLETED
Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome
Lead Sponsor:
Air Liquide Santé International
Collaborating Sponsors:
Atlanstat
Conditions:
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 dete...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01441622
Start Date
June 1 2011
End Date
April 1 2012
Last Update
June 30 2014
Active Locations (1)
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1
Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance
Paris, France, 75181