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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance
Paris, France, 75181

Sponsors and Collaborators

Air Liquide Santé International

ATLANSTAT

Investigators

Principal Investigator:	Damien LEGER, Pr	Hôpital Hôtel Dieu

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leger D, Elbaz M, Piednoir B, Carron A, Texereau J. Evaluation of the add-on NOWAPI® medical device for remote monitoring of compliance to Continuous Positive Airway Pressure and treatment efficacy in obstructive sleep apnea. Biomed Eng Online. 2016 Feb 27;15:26. doi: 10.1186/s12938-016-0139-4.

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
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