Evaluation of a New Medical Device AL539 in Patients With... | NCT01441622

Studies
Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome

NCT01441622

Sponsor

Air Liquide Santé International

Status

Completed

Last Update Posted

Jun 30, 2014Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

AL539 (SRETT)

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IDR CB / 2010-A00923-36	Other Identifier	AFSSAPS

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Sep 16, 2011

First Submission Date that Met QC Criteria

Sep 26, 2011

First Posted Date

Sep 27, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2014

Last Update Posted Date

Jun 30, 2014Estimated

Name	Class
Atlanstat	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AL539	Experimental	Device AL539	Device: AL539 (SRETT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AL539 (SRETT)	Device	recording data with AL539 (SRETT)	AL539	Manufacturer name : SRETT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CPAP treatment duration	Continous Positive Airway Pressure treatment duration	up to 12 hours

Secondary Outcomes

Measure	Description	Time Frame
Apneas-Hypopneas	Apneas-Hypopneas Index (AHI) and Apneas Index (AI)	up to 12 hours
Mean pressure	Mean pressure in patient circuit

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Damien LEGER, Pr	Hôpital Hôtel Dieu	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance		Paris		75181	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26922498	Derived	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.

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases