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

This study has been completed.
Sponsor:
Collaborator:
ATLANSTAT
Information provided by (Responsible Party):
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT01441622
First received: September 16, 2011
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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 Intervention
Obstructive Sleep Apnea Syndrome
Device: AL539 (SRETT)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:
  • CPAP treatment duration [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]
    Continous Positive Airway Pressure treatment duration


Secondary Outcome Measures:
  • Apneas-Hypopneas [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]
    Apneas-Hypopneas Index (AHI) and Apneas Index (AI)

  • Mean pressure [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]
    Mean pressure in patient circuit

  • Mean Flow [ Time Frame: up to 12 hours ] [ Designated as safety issue: No ]
    Mean flow rate in patient circuit


Enrollment: 20
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL539
Device AL539
Device: AL539 (SRETT)
recording data with AL539 (SRETT)
Other Name: Manufacturer name : SRETT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441622

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

No publications provided

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
Study First Received: September 16, 2011
Last Updated: June 27, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Air Liquide Santé International:
Continuous Positive Airway Pressure (CPAP)
AL539
Home-monitoring

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

ClinicalTrials.gov processed this record on July 20, 2014