Obstructive Sleep Apnea SyndromeAL539NCT01441622
Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome
A study testing AL539 (SRETT) in people with Obstructive Sleep Apnea Syndrome, run by Air Liquide Santé International at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- AL539 (SRETT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Hôtel DIEU - Centre du sommeil et de la Vigilance
Paris, 75181
About this study
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
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- AL539 (SRETT)
- Keywords
- Continuous Positive Airway Pressure (CPAP), AL539, Home-monitoring
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL539 (SRETT)Device
Also called Manufacturer name : SRETT
recording data with AL539 (SRETT)
| Study group | Role | What they receive |
|---|---|---|
| AL539 | Experimental | Device AL539 Receives: Device: AL539 (SRETT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP treatment duration
Continous Positive Airway Pressure treatment duration
Measured: up to 12 hours
Secondary outcomes (3)
Apneas-Hypopneas
Apneas-Hypopneas Index (AHI) and Apneas Index (AI)
Measured: up to 12 hours
Mean pressure
Mean pressure in patient circuit
Measured: up to 12 hours
Mean Flow
Mean flow rate in patient circuit
Measured: up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startJun 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide Santé International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlanstat
- Responsible party
- Sponsor
- Investigators
- Damien LEGER, Pr, Principal investigator, Hôpital Hôtel Dieu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441622
- Sponsor's protocol ID
- ALMED-10-MD-030
- Other IDs
- IDR CB / 2010-A00923-36
- Acronym
- AL539
- Status last verified
- Jun 2014
- First submitted
- 16 Sep 2011
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26922498
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01441622
- Acronym / sponsor ID
- AL539 / ALMED-10-MD-030
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Continuous Positive Airway Pressure (CPAP), AL539, Home-monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Air Liquide Santé InternationalIndustry (pharma, biotech, devices)
- Collaborators
- Atlanstat
- Study start
- Jun 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL539 | Experimental | Device: AL539 (SRETT)Device AL539 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL539 (SRETT)Also: Manufacturer name : SRETTrecording data with AL539 (SRETT) | Device | AL539 |
Primary outcome
CPAP treatment duration
Time frame: up to 12 hours
Continous Positive Airway Pressure treatment duration
3 secondary outcomes
Apneas-Hypopneas
Time frame: up to 12 hours
Mean pressure
Time frame: up to 12 hours
Mean Flow
Time frame: up to 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
- Derived from this study: PubMed 26922498Leger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damien LEGER, Pr principal investigator
Hôpital Hôtel Dieu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AL539 (SRETT) in people with Obstructive Sleep Apnea Syndrome, run by Air Liquide Santé International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP treatment duration (time frame: up to 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01441622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2014.