Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome
NCT ID: NCT01441622
Last Updated: 2014-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2011-06-30
2012-04-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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AL539
Device AL539
AL539 (SRETT)
recording data with AL539 (SRETT)
Interventions
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AL539 (SRETT)
recording data with AL539 (SRETT)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Atlanstat
INDUSTRY
Air Liquide Santé International
INDUSTRY
Responsible Party
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Principal Investigators
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Damien LEGER, Pr
Role: PRINCIPAL_INVESTIGATOR
Hôpital Hôtel Dieu
Locations
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Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance
Paris, , France
Countries
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References
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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.
Other Identifiers
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IDR CB / 2010-A00923-36
Identifier Type: OTHER
Identifier Source: secondary_id
ALMED-10-MD-030
Identifier Type: -
Identifier Source: org_study_id