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Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography

Primary Purpose

Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Analysis with AED and manual PSG scoring

About this trial

This is an interventional diagnostic trial for Sleep Apnea

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 continuous positive airway pressure (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

Sites / Locations

Shands and UF Sleep Disorder Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP Device

Arm Description

Breathing event detection (AED) by the CPAP device will be compared to breathing event detection by a simultaneous PSG (manual PSG scoring).

Outcomes

Primary Outcome Measures

Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm

Apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. The Apnea index (AI) is the average number of apneas that occur per hour of sleep. The Hypopnea index (HI) is the average number of hypopneas that occur per hour of sleep. The PSGs were manually scored to determine the apnea-hypopnea index. This value was then compared to the PAP device which utilized the AED algorithm to determine the apnea-hypopnea index.

Secondary Outcome Measures

Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC)

Methodological comparisons utilizing ICC for detection of AHI, apnea index (AI) and hypopnea index (HI) were caculated between the values obtained by PSG and the REMstar Auto with A-Flex device.

Full Information

NCT ID

NCT00836758

First Posted

February 3, 2009

Last Updated

December 27, 2018

Sponsor

Philips Respironics

1. Study Identification

Unique Protocol Identification Number

NCT00836758

Brief Title

Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Philips Respironics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The 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

Purpose: The purpose of this study was to compare the AED algorithm used in a PAP device with manually scored events on PSG. The PAP device was modified to produce a square wave voltage output identifying when apneas, hypopneas, and snoring events were detected. Recording this event signal on the PSG performed with the patient using the PAP device allowed an event-by-event comparison between manually scored PSG events and AED events. In addition, the AHI, AI, and HI derived from the manually scored PSG were compared with the respective measures reported by the PAP device used during the PSG. Study Objectives: Compare automatic event detection (AED) of respiratory events using a positive airway pressure (PAP) device with manual scoring of polysomnography (PSG) during PAP treatment of obstructive sleep apnea (OSA). Design: Prospective PSGs of patients using a PAP device. Setting: Six academic and private sleep disorders centers. Interventions: A signal generated by the PAP device identifying the AED of respiratory events based on airflow was recorded during PSG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Participants wore a PAP device and had a PSG at the same time. These participants had their PSG data compared to the PAP data.

Masking

None (Open Label)

Allocation

N/A

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPAP Device

Arm Type

Experimental

Arm Description

Breathing event detection (AED) by the CPAP device will be compared to breathing event detection by a simultaneous PSG (manual PSG scoring).

Intervention Type

Device

Intervention Name(s)

Analysis with AED and manual PSG scoring

Intervention Description

The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring.

Primary Outcome Measure Information:

Title

Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm

Description

Time Frame

one night

Secondary Outcome Measure Information:

Title

Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC)

Description

Methodological comparisons utilizing ICC for detection of AHI, apnea index (AI) and hypopnea index (HI) were caculated between the values obtained by PSG and the REMstar Auto with A-Flex device.

Time Frame

one night

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 continuous positive airway pressure (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: moderate to severe periodic limb movements(≥ 30/hr with symptoms or arousals) arousals associated with periodic limb movements > 10 per hour or anyone experiencing chronic and severe insomnia. Consumption of ethanol immediately prior to the research PSG

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Berry, MD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shands and UF Sleep Disorder Center

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32606

Country

United States

12. IPD Sharing Statement

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Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography

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