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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01441622
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : June 30, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Syndrome Device: AL539 (SRETT) Not Applicable

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AL539
Device AL539
Device: AL539 (SRETT)
recording data with AL539 (SRETT)
Other Name: Manufacturer name : SRETT

Primary Outcome Measures :
  1. CPAP treatment duration [ Time Frame: up to 12 hours ]
    Continous Positive Airway Pressure treatment duration

Secondary Outcome Measures :
  1. Apneas-Hypopneas [ Time Frame: up to 12 hours ]
    Apneas-Hypopneas Index (AHI) and Apneas Index (AI)

  2. Mean pressure [ Time Frame: up to 12 hours ]
    Mean pressure in patient circuit

  3. 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01441622

Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance
Paris, France, 75181
Sponsors and Collaborators
Air Liquide Santé International
Principal Investigator: Damien LEGER, Pr Hôpital Hôtel Dieu

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Air Liquide Santé International 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)

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases