Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)
NCT ID: NCT01010438
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
59 participants
OBSERVATIONAL
2009-10-31
2011-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RETROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients consented or for whom legal guardians consented for the participation of this trial.
* Patient recommended for a Sleep assessment by medical staff.
Exclusion Criteria
1 Year
ALL
No
Sponsors
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Oridion
INDUSTRY
Responsible Party
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Principal Investigators
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Giora Pillar, MD
Role: PRINCIPAL_INVESTIGATOR
Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit, Rambam Health Care Campus
Locations
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Hillel Yaffe Sleep Lab Center
Hadera, , Israel
Prof. Giora Pillar M.D., Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit
Haifa, , Israel
Hadassah Sleep Lab Center
Jerusalem, , Israel
Countries
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References
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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.
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.
Other Identifiers
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D006567
Identifier Type: -
Identifier Source: org_study_id