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

Obstructive Sleep Apnea Syndrome Clinical Trial

— AL539  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441622
• Other study ID #: ALMED-10-MD-030
• Secondary ID: IDR CB / 2010-A0
• Status: Completed
• Phase: N/A
• First received: September 16, 2011
• Last updated: June 27, 2014
• Start date: June 2011
• Est. completion date: April 2012

Study information

• Verified date: June 2014
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• AL539 (SRETT)
recording data with AL539 (SRETT)

Locations

Country	Name	City	State
France	Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Air Liquide Santé International	ATLANSTAT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP treatment duration	Continous Positive Airway Pressure treatment duration	up to 12 hours	No
Secondary	Apneas-Hypopneas	Apneas-Hypopneas Index (AHI) and Apneas Index (AI)	up to 12 hours	No
Secondary	Mean pressure	Mean pressure in patient circuit	up to 12 hours	No
Secondary	Mean Flow	Mean flow rate in patient circuit	up to 12 hours	No