Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome
AL539
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
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 16, 2011
CompletedFirst Posted
Study publicly available on registry
September 27, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedJune 30, 2014
June 1, 2014
10 months
September 16, 2011
June 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CPAP treatment duration
Continous Positive Airway Pressure treatment duration
up to 12 hours
Secondary Outcomes (3)
Apneas-Hypopneas
up to 12 hours
Mean pressure
up to 12 hours
Mean Flow
up to 12 hours
Study Arms (1)
AL539
EXPERIMENTALDevice AL539
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Air Liquide Santé Internationallead
- Atlanstatcollaborator
Study Sites (1)
Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance
Paris, 75181, France
Related Publications (1)
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.
PMID: 26922498DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Damien LEGER, Pr
Hôpital Hôtel Dieu
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2011
First Posted
September 27, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
June 30, 2014
Record last verified: 2014-06