Clinical trial NCT01010438: Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: sleep studies
sleep apnea
OSA
Referred for sleep studies by a medical professional
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 59
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

Brief 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. 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.

Eligibility 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.

Primary outcomes:
measure: Comparison of apnea event detection
timeFrame: Apnea events are defined as events that last at least 10 seconds
Secondary outcomes:
measure: Validation of apnea index
timeFrame: Post study analysis
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Sleep Lab Center
city: Haifa
country: Israel
facility: Prof. Giora Pillar M.D., Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit
city: Jerusalem
country: Israel
facility: Hadassah Sleep Lab Center
Study officials:
affiliation: Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit, Rambam Health Care Campus
name: Giora Pillar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and Technical Specification/ Con Iber, MD/ AASM - 2007
citation: 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.
citation: 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.