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

June 27, 2014 updated by: Air Liquide Santé International

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AL539
Device AL539
Device: AL539 (SRETT)
recording data with AL539 (SRETT)
Other Names:
  • Manufacturer name : SRETT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP treatment duration
Time Frame: up to 12 hours
Continous Positive Airway Pressure treatment duration
up to 12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apneas-Hypopneas
Time Frame: up to 12 hours
Apneas-Hypopneas Index (AHI) and Apneas Index (AI)
up to 12 hours
Mean pressure
Time Frame: up to 12 hours
Mean pressure in patient circuit
up to 12 hours
Mean Flow
Time Frame: up to 12 hours
Mean flow rate in patient circuit
up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Liquide Santé International

Collaborators

Atlanstat

Investigators

  • Principal Investigator: Damien LEGER, Pr, Hôpital Hotel Dieu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 16, 2011

First Submitted That Met QC Criteria

September 26, 2011

First Posted (Estimate)

September 27, 2011

Study Record Updates

Last Update Posted (Estimate)

June 30, 2014

Last Update Submitted That Met QC Criteria

June 27, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALMED-10-MD-030
  • IDR CB / 2010-A00923-36 (Other Identifier: AFSSAPS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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