Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome (AL539)
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ClinicalTrials.gov Identifier: NCT01441622 |
Recruitment Status
:
Completed
First Posted
: September 27, 2011
Last Update Posted
: June 30, 2014
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obstructive Sleep Apnea Syndrome | Device: AL539 (SRETT) | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | 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 |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: AL539
Device AL539
|
Device: AL539 (SRETT)
recording data with AL539 (SRETT)
Other Name: Manufacturer name : SRETT
|
- CPAP treatment duration [ Time Frame: up to 12 hours ]Continous Positive Airway Pressure treatment duration
- Apneas-Hypopneas [ Time Frame: up to 12 hours ]Apneas-Hypopneas Index (AHI) and Apneas Index (AI)
- Mean pressure [ Time Frame: up to 12 hours ]Mean pressure in patient circuit
- Mean Flow [ Time Frame: up to 12 hours ]Mean flow rate in patient circuit

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01441622
France | |
Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance | |
Paris, France, 75181 |
Principal Investigator: | Damien LEGER, Pr | Hôpital Hôtel Dieu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Air Liquide Santé International |
ClinicalTrials.gov Identifier: | NCT01441622 History of Changes |
Other Study ID Numbers: |
ALMED-10-MD-030 IDR CB / 2010-A00923-36 ( Other Identifier: AFSSAPS ) |
First Posted: | September 27, 2011 Key Record Dates |
Last Update Posted: | June 30, 2014 |
Last Verified: | June 2014 |
Keywords provided by Air Liquide Santé International:
Continuous Positive Airway Pressure (CPAP) AL539 Home-monitoring |
Additional relevant MeSH terms:
Syndrome Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Disease Pathologic Processes Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |