Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oridion
ClinicalTrials.gov Identifier:
NCT01010438
First received: November 8, 2009
Last updated: March 12, 2012
Last verified: March 2012

November 8, 2009
March 12, 2012
October 2009
July 2011   (final data collection date for primary outcome measure)
Comparison of apnea event detection [ Time Frame: Apnea events are defined as events that last at least 10 seconds ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010438 on ClinicalTrials.gov Archive Site
Validation of apnea index [ Time Frame: Post study analysis ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)
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.

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.

Observational
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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.

Obstructive Sleep Apnea
Not Provided
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
December 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients who in the opinion of the investigator should not participate.
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01010438
D006567
Yes
Oridion
Oridion
Not Provided
Principal Investigator: Giora Pillar, MD Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit, Rambam Health Care Campus
Oridion
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP