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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- CPAP treatment duration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
CPAP treatment duration
Time Frame: up to 12 hours
Continous Positive Airway Pressure treatment duration
Secondary Outcomes
- Apneas-Hypopneas(up to 12 hours)
- Mean pressure(up to 12 hours)
- Mean Flow(up to 12 hours)