Sleep Apnea, ObstructiveGETEMEDNCT01720823
Obstructive Sleep Apnea Syndrome (OSA) and Getemed
A study testing home polysomnography (GETEMED) and standard polysomnography (BRAINNET II) in people with Sleep Apnea, Obstructive, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- home polysomnography (GETEMED) and standard polysomnography (BRAINNET II)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Jan 2016
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female subjects, aged 2 to 6 years old, requiring a polysomnography or admitted for intense snoring or suspected sleep apnea
- Parents must have signed the inform consent form and be covered by the National Health Insurance Program.
Who cannot join
- Parents opposed to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study
It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.
Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- home polysomnography (GETEMED), standard polysomnography (BRAINNET II)
- Keywords
- Obstructive Sleep Apnea syndrome, polysomnography, 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.
home polysomnography (GETEMED)Device
Also called GETEMED
standard polysomnography (BRAINNET II)Device
Also called BRAINNET II
| Study group | Role | What they receive |
|---|---|---|
| home polysomnography and standard polysomnography | Experimental | home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night. Receives: Device: home polysomnography (GETEMED); Device: standard polysomnography (BRAINNET II) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.
- Standard polysomnography considered pathological if obstructive apnea-hypopnea index (AHI) > 5 / hr.
- Home polysomnography considered pathological if at least one of the following criteria is present :
- Respiratory Disturbance Index (RDI) > 10 / hr + /- Desaturation Index > 4% for more than 2.5 / hr.
- Brouillette index ; pulse wave > 3 desaturation clusters and > 3 desaturation <90%.
Measured: 1 night
Secondary outcomes (1)
To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography.
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia FRANCO, MD, Principal investigator, Hospices Civils de Lyon- Hôpital Femme Mère Enfant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720823
- Sponsor's protocol ID
- 2009.589
- Acronym
- GETEMED
- Status last verified
- Apr 2016
- First submitted
- 31 Oct 2012
- Last updated
- 5 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Characteristics of a Home Polysomnograph for the Diagnosis of Patients With Obstructive Sleep Apnea Syndrome - A Pilot Study
- ClinicalTrials.gov ID
- NCT01720823
- Acronym / sponsor ID
- GETEMED / 2009.589
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea syndrome, polysomnography, Home monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 2 Nov 2012 (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.
It is often clinically impossible to differentiate children with an isolated snoring from those with OSA. The diagnosis of OSA is currently based on nocturnal, laboratory-based polysomnography. This expensive examination is poorly accessible due to appointments delays at hospital.
Our study is designed to compare the characteristics of a home polysomnography versus standard polysomnography for the diagnosis of pediatric OSA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| home polysomnography and standard polysomnography | Experimental | Device: home polysomnography (GETEMED), Device: standard polysomnography (BRAINNET II)home polysomnography (GETEMED) and standard polysomnography (BRAINNETII) are both carried out in children during 1 night. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female subjects, aged 2 to 6 years old, requiring a polysomnography or admitted for intense snoring or suspected sleep apnea
- Parents must have signed the inform consent form and be covered by the National Health Insurance Program.
Key exclusion criteria (1 listed)
- Parents opposed to the study.
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 |
|---|---|---|
| home polysomnography (GETEMED)Also: GETEMED | Device | home polysomnography and standard polysomnography |
| standard polysomnography (BRAINNET II)Also: BRAINNET II | Device | home polysomnography and standard polysomnography |
Primary outcome
Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children.
Time frame: 1 night
* Standard polysomnography considered pathological if obstructive apnea-hypopnea index (AHI) > 5 / hr. * Home polysomnography considered pathological if at least one of the following criteria is present : 1. Respiratory Disturbance Index (RDI) > 10 / hr + /- Desaturation Index > 4% for more than 2.5 / hr. 2. Brouillette index ; pulse wave > 3 desaturation clusters and > 3 desaturation <90%.
1 secondary outcome
To determine polygraphic pathological criteria by comparing the RDI per hour of the home polysomnography versus the (AHI) of the standard polysomnography.
Time frame: 1 night
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 5 Apr 2016.
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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.
Patricia FRANCO, MD principal investigator
Hospices Civils de Lyon- Hôpital Femme Mère Enfant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home polysomnography (GETEMED) and standard polysomnography (BRAINNET II) in people with Sleep Apnea, Obstructive, run by Hospices Civils de Lyon 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 2 inclusion and 1 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 5 Apr 2016. 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?
Characteristics of a home polysomnograph versus standard polysomnography for the diagnosis of OSA in children. (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2016.