Obstructive Sleep ApneaNCT01010438
Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)
An observational study of Obstructive Sleep Apnea, run by Oridion at 3 sites in Israel.
Trial summary
The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 59 participants
- Where
- 3 sitesIsrael
- Study dates
- Oct 2009to Dec 2011
- Phase
- Observational
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Population includes consented adult patients and pediatric patients from 3 sites that have been referred for sleep studies by a medical professional. The study will include both patients with suspected OSA and patients that have been invited to a sleep lab for reasons not related to OSA such as insomnia, para-insomnia and similar.
Who may be able to join
- All Adults > 18 years old and able to understand and give consent per the IRB or a child above one years old consented by a parent or legal guardians.
- Patients consented or for whom legal guardians consented for the participation of this trial.
- Patient recommended for a Sleep assessment by medical staff.
Who cannot join
- Patients who in the opinion of the investigator should not participate.
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Hillel Yaffe Sleep Lab Center
Hadera
Prof. Giora Pillar M.D., Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit
Haifa
Hadassah Sleep Lab Center
Jerusalem
About this study
Official title: Clinical Evaluation of an Apnea Index Provided by a Capnograph/Pulse Oximeter to Assist in the Diagnosis and Screening of Obstructive Sleep Apnea
The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst. The study will compare the apnea index score (AI) calculated by the Capnostream 20 algorithm based on capnography to that calculated by a trained analyst evaluating polysomnograph recordings.
To this aim, subjects will be connected to EMBLA N7000 Polysomnograph, and to the Capnostream 20, in order to monitor CO2 and SpO2 during routine overnight sleep studies.
Read more
The Capnostream, using both its USB Data Port and Analog output port will simultaneously provide the monitored data both to a USB flash memory device and Polysomnograph for storage for future analysis.
The data collected by the Polysomnograph including the Capnostream data will be analyzed by a trained expert for evaluation of apnea events obtained from both sources.
In parallel, the Capnostream data as collected with the USB flash memory, will be downloaded onto a PC, and using the Oridion software algorithm designed for evaluating the data (to be implemented in the monitor when validated), the Apnea Index and Oxygen Desaturation Index will be calculated. The results of the Apnea Index scores calculated from the Polysomnograph and from the DUT will be compared.
Based on the results, the study will then evaluate the ability of the Capnograph/Pulse-Oximeter as a tool for screening and assisting in the diagnosis of patients with obstructive sleep-apnea in the hospital environment, where it is being used as a ventilation monitor based on the demonstration of a high correlation with the gold standard in the sleep lab.
Read the detailed description
The clinical investigation will be conducted until enrollment of at least 30 adult and 30 Pediatric patients of both sexes with complete data sets are collected from three different sleep lab sites per the FDA guidance requirements. The enrollment time will last up to six (6) months. The overall number of enrolled patients (i.e. with complete/incomplete data) will not exceed 80 patients.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep studies, sleep apnea, OSA, Referred for sleep studies by a medical professional
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults | Adult patients referred for sleep studies, including both patients with suspected OSA and patients that have been invited to a sleep lab for reasons not related to OSA such as insomnia, para-insomnia and similar. | |
| Children (1-17) | Pediatric patients referred for sleep studies, including both patients with suspected OSA and patients that have been invited to a sleep lab for reasons not related to OSA such as insomnia, para-insomnia and similar. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of apnea event detection
Measured: Apnea events are defined as events that last at least 10 seconds
Secondary outcomes (1)
Validation of apnea index
Measured: Post study analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oridion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giora Pillar, MD, Principal investigator, Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010438
- Sponsor's protocol ID
- D006567
- Status last verified
- Nov 2016
- First submitted
- 8 Nov 2009
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dangers of Postoperative Opioids - APSF Workshop and White Paper Address Prevention of Postoperative Respiratory Complications /Matthew B. Weinger, MD/APSF Newsletter Volume 21, No. 4, 61-88Winter 2006-2007
The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specification/ Con Iber, MD/ AASM - 2007
Ng SS, Chan TO, To KW, Ngai J, Tung A, Ko FW, Hui DS. Validation of a portable recording device (ApneaLink) for identifying patients with suspected obstructive sleep apnoea syndrome. Intern Med J. 2009 Nov;39(11):757-62. doi: 10.1111/j.1445-5994.2008.01827.x. Epub 2008 Nov 3.
PubMed 19220528de Almeida FR, Ayas NT, Otsuka R, Ueda H, Hamilton P, Ryan FC, Lowe AA. Nasal pressure recordings to detect obstructive sleep apnea. Sleep Breath. 2006 Jun;10(2):62-9. doi: 10.1007/s11325-005-0042-x.
PubMed 16502297
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Apnea Index Provided by a Capnograph/Pulse Oximeter to Assist in the Diagnosis and Screening of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01010438
- Acronym / sponsor ID
- D006567
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep studies, sleep apnea, OSA, Referred for sleep studies by a medical professional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- OridionIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Nov 2009 (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.
The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst. The study will compare the apnea index score (AI) calculated by the Capnostream 20 algorithm based on capnography to that calculated by a trained analyst evaluating polysomnograph recordings.
To this aim, subjects will be connected to EMBLA N7000 Polysomnograph, and to the Capnostream 20, in order to monitor CO2 and SpO2 during routine overnight sleep studies.
The Capnostream, using both its USB Data Port and Analog output port will simultaneously provide the monitored data both to a USB flash memory device and Polysomnograph for storage for future analysis.
The data collected by the Polysomnograph including the Capnostream data will be analyzed by a trained expert for evaluation of apnea events obtained from both sources.
In parallel, the Capnostream data as collected with the USB flash memory, will be downloaded onto a PC, and using the Oridion software algorithm designed for evaluating the data (to be implemented in the monitor when validated), the Apnea Index and Oxygen Desaturation Index will be calculated. The results of the Apnea Index scores calculated from the Polysomnograph and from the DUT will be compared.
Based on the results, the study will then evaluate the ability of the Capnograph/Pulse-Oximeter as a tool for screening and assisting in the diagnosis of patients with obstructive sleep-apnea in the hospital environment, where it is being used as a ventilation monitor based on the demonstration of a high correlation with the gold standard in the sleep lab.
Detailed description
The clinical investigation will be conducted until enrollment of at least 30 adult and 30 Pediatric patients of both sexes with complete data sets are collected from three different sleep lab sites per the FDA guidance requirements. The enrollment time will last up to six (6) months. The overall number of enrolled patients (i.e. with complete/incomplete data) will not exceed 80 patients.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adults | – | –Adult patients referred for sleep studies, including both patients with suspected OSA and patients that have been invited to a sleep lab for reasons not related to OSA such as insomnia, para-insomnia and similar. |
| Children (1-17) | – | –Pediatric patients referred for sleep studies, including both patients with suspected OSA and patients that have been invited to a sleep lab for reasons not related to OSA such as insomnia, para-insomnia and similar. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population includes consented adult patients and pediatric patients from 3 sites that have been referred for sleep studies by a medical professional. The study will include both patients with suspected OSA and patients that have been invited to a sleep lab for reasons not related to OSA such as insomnia, para-insomnia and similar.
Key inclusion criteria (3 listed)
- All Adults > 18 years old and able to understand and give consent per the IRB or a child above one years old consented by a parent or legal guardians.
- Patients consented or for whom legal guardians consented for the participation of this trial.
- Patient recommended for a Sleep assessment by medical staff.
Key exclusion criteria (1 listed)
- Patients who in the opinion of the investigator should not participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of apnea event detection
Time frame: Apnea events are defined as events that last at least 10 seconds
1 secondary outcome
Validation of apnea index
Time frame: Post study analysis
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 2 Nov 2016.
- BackgroundDangers of Postoperative Opioids - APSF Workshop and White Paper Address Prevention of Postoperative Respiratory Complications /Matthew B. Weinger, MD/APSF Newsletter Volume 21, No. 4, 61-88Winter 2006-2007
- BackgroundThe AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specification/ Con Iber, MD/ AASM - 2007
- Background: PubMed 19220528Ng SS, Chan TO, To KW, Ngai J, Tung A, Ko FW, Hui DS. Validation of a portable recording device (ApneaLink) for identifying patients with suspected obstructive sleep apnoea syndrome. Intern Med J. 2009 Nov;39(11):757-62. doi: 10.1111/j.1445-5994.2008.01827.x. Epub 2008 Nov 3.
- Background: PubMed 16502297de Almeida FR, Ayas NT, Otsuka R, Ueda H, Hamilton P, Ryan FC, Lowe AA. Nasal pressure recordings to detect obstructive sleep apnea. Sleep Breath. 2006 Jun;10(2):62-9. doi: 10.1007/s11325-005-0042-x.
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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.
Giora Pillar, MD principal investigator
Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit, Rambam Health Care Campus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Oridion at 3 sites in Israel.
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 3 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. 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?
Comparison of apnea event detection (time frame: Apnea events are defined as events that last at least 10 seconds). 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 NCT01010438, which also lists 4 linked publications.
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 2 Nov 2016.