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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of apnea event detection | Apnea events are defined as events that last at least 10 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of apnea index | Post study analysis |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Giora Pillar, MD | Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit, Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe Sleep Lab Center | Hadera | Israel | ||||
| Prof. Giora Pillar M.D., Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| Background | The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specification/ Con Iber, MD/ AASM - 2007 | ||
| 19220528 | Background | 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. | |
| 16502297 |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Haifa |
| Israel |
| Hadassah Sleep Lab Center | Jerusalem | Israel |
| Background |
| de 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. |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |