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Completed

NCT Number: NCT01441622

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance

Paris, 75181, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AL539 (SRETT)

Device

recording data with AL539 (SRETT)

Other names: Manufacturer name : SRETT

Primary outcomes

  1. CPAP treatment duration

    Time frame: up to 12 hours

    Continous Positive Airway Pressure treatment duration

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Air Liquide Santé International

Industry

Collaborators

  • Atlanstat

Registry information

Official study 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

Acronym: AL539

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 27, 2011
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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