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

Primary Purpose

Obstructive Sleep Apnea Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

AL539 (SRETT)

About this trial

This is an interventional health services research trial for Obstructive Sleep Apnea Syndrome focused on measuring Continuous Positive Airway Pressure (CPAP), AL539, Home-monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AL539

Arm Description

Device AL539

Outcomes

Primary Outcome Measures

CPAP treatment duration

Continous Positive Airway Pressure treatment duration

Secondary Outcome Measures

Apneas-Hypopneas

Apneas-Hypopneas Index (AHI) and Apneas Index (AI)

Mean pressure

Mean pressure in patient circuit

Mean Flow

Mean flow rate in patient circuit

Full Information

NCT ID

NCT01441622

First Posted

September 16, 2011

Last Updated

June 27, 2014

Sponsor

Air Liquide Santé International

Collaborators

Atlanstat

1. Study Identification

Unique Protocol Identification Number

NCT01441622

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Air Liquide Santé International

Collaborators

Atlanstat

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea Syndrome

Keywords

Continuous Positive Airway Pressure (CPAP), AL539, Home-monitoring

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AL539

Arm Type

Experimental

Arm Description

Device AL539

Intervention Type

Device

Intervention Name(s)

AL539 (SRETT)

Other Intervention Name(s)

Manufacturer name : SRETT

Intervention Description

recording data with AL539 (SRETT)

Primary Outcome Measure Information:

Title

CPAP treatment duration

Description

Continous Positive Airway Pressure treatment duration

Time Frame

up to 12 hours

Secondary Outcome Measure Information:

Title

Apneas-Hypopneas

Description

Apneas-Hypopneas Index (AHI) and Apneas Index (AI)

Time Frame

up to 12 hours

Title

Mean pressure

Description

Mean pressure in patient circuit

Time Frame

up to 12 hours

Title

Mean Flow

Description

Mean flow rate in patient circuit

Time Frame

up to 12 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Damien LEGER, Pr

Organizational Affiliation

Hôpital Hôtel Dieu

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance

City

Paris

ZIP/Postal Code

75181

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

26922498

Citation

Leger D, Elbaz M, Piednoir B, Carron A, Texereau J. Evaluation of the add-on NOWAPI(R) 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.

Results Reference

derived

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

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