Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography

This study has been completed.

Sponsor:

Information provided by:

Philips Respironics

ClinicalTrials.gov Identifier:

NCT00836758

First received: February 3, 2009

Last updated: July 28, 2010

Last verified: July 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 3, 2009

Last Updated Date

July 28, 2010

Start Date ^ICMJE

February 2009

Primary Completion Date

August 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evidence of diagnostic agreement between breathing events identified by the CPAP device compared to a simultaneous PSG confirmed by using accepted sleep disordered breathing severity groupings (AHI >5, AHI >15 and AHI >30). [AHI is apnea-hypopnea index] [ Time Frame: one night ]

Participants will undergo an attended PSG using the CPAP device at a sub-therapeutic pressure in order to induce breathing events. The breathing event outputs for both the PSG and CPAP device will be compared to determine if the apnea-hypopnea indices are in diagnostic agreement.

Original Primary Outcome Measures ^ICMJE

The CPAP device breathing event output will result in an apnea-hypopnea index (AHI) that is in diagnostic agreement with the AHI obtained from a full clinical PSG. [ Time Frame: one night ]

Change History

Complete list of historical versions of study NCT00836758 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Methodological comparisons of AHI, apnea index (AI) and hypopnea index (HI) will demonstrate agreement between the values obtained by PSG and the CPAP device. [ Time Frame: one night ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparison of Breathing Event Detection by a CPAP Device to Clinical Polysomnography

Official Title ^ICMJE

Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography

Brief Summary

The purpose of this study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep apnea.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Sleep Apnea

Intervention ^ICMJE

Device: REMstar Auto with A-Flex

The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated.

Study Arms

Experimental: CPAP Device

Breathing event detection by the CPAP device will be compared to breathing event detection by a simultaneous PSG.

Intervention: Device: REMstar Auto with A-Flex

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2009

Primary Completion Date

August 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 21-75
Diagnosis of OSAHS with a baseline AHI ≥ 15 events/hr of sleep assessed January 01, 2007 or later
CPAP prescription of 8cm of H20 or higher
Able and willing to provide written informed consent
Native English speaker

Exclusion Criteria:

Participation in another interventional research study within the last 30 days
Major medical or psychiatric condition that would interfere with the demands of the study and adherence to PAP. Examples include unstable cardiovascular disease (Class III / IV CHF), neuromuscular disease, cancer, and renal failure.
Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (> 45 mmHg) while awake, or subjects requiring continuous oxygen therapy.
Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
Presence of untreated or poorly managed,non-OSAHS related sleep disorders:
1. moderate to severe periodic limb movements(≥ 30/hr with symptoms or arousals)
2. arousals associated with periodic limb movements > 10 per hour or
3. anyone experiencing chronic and severe insomnia.
Consumption of ethanol immediately prior to the research PSG

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years to 75 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00836758

Other Study ID Numbers ^ICMJE

EDILP-2008-SST-01

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Post-Marketing Clinical Research Manager, Philips/Respironics

Study Sponsor ^ICMJE

Philips Respironics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Richard Berry, MD

University of Florida

PRS Account

Philips Respironics

Verification Date

July 2010

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

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