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
  Purpose

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.


Condition
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Oridion:

Primary Outcome Measures:
  • Comparison of apnea event detection [ Time Frame: Apnea events are defined as events that last at least 10 seconds ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Validation of apnea index [ Time Frame: Post study analysis ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010438

Locations
Israel
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
Sponsors and Collaborators
Oridion
Investigators
Principal Investigator: Giora Pillar, MD Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit, Rambam Health Care Campus
  More Information

Publications:
Responsible Party: Oridion
ClinicalTrials.gov Identifier: NCT01010438     History of Changes
Other Study ID Numbers: D006567
Study First Received: November 8, 2009
Last Updated: March 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oridion:
sleep studies
sleep apnea
OSA
Referred for sleep studies by a medical professional

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014