Clinical trial NCT01441622: Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Continuous Positive Airway Pressure (CPAP)
AL539
Home-monitoring
Lead sponsor: Air Liquide Santé International
Sponsor class: INDUSTRY
Collaborators: name: Atlanstat
First posted: 2011-09-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: CPAP treatment duration
timeFrame: up to 12 hours
Secondary outcomes:
measure: Apneas-Hypopneas
timeFrame: up to 12 hours
measure: Mean pressure
timeFrame: up to 12 hours
measure: Mean Flow
timeFrame: up to 12 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance
Study officials:
affiliation: Hôpital Hôtel Dieu
name: Damien LEGER, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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.