Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome (AL539)
This study has been completed.
Sponsor:
Air Liquide Santé International
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
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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 (Adult, Senior) |
| 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
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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
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
|
Syndrome Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Disease Pathologic Processes Respiration Disorders |
Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on September 30, 2016