Obstructive Sleep Apnea Syndrome
Conditions
Keywords
Continuous Positive Airway Pressure (CPAP), AL539, Home-monitoring
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.
Interventions
DEVICEAL539 (SRETT)
recording data with AL539 (SRETT)
Sponsors
Atlanstat
Air Liquide Santé International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CPAP treatment duration | up to 12 hours | Continous Positive Airway Pressure treatment duration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apneas-Hypopneas | up to 12 hours | Apneas-Hypopneas Index (AHI) and Apneas Index (AI) |
| Mean pressure | up to 12 hours | Mean pressure in patient circuit |
| Mean Flow | up to 12 hours | Mean flow rate in patient circuit |
Countries
France
Outcome results
None listed