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CompletedNCT00836758Updated Jan 16, 2019Results posted

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

An interventional study of Analysis with AED and manual PSG scoring in Sleep Apnea, sponsored by Philips Respironics. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-01-16.

Sponsored by Philips Respironics · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
115
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Sleep Apnea
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In context

Sleep Apnea Syndromes

2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 291 are open to participants now.

This study's enrollment of 115 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Philips Respironics is the lead sponsor of 40 studies on the registry; none are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Participation in another interventional research study within the last 30 days
  2. 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.
  3. 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.
  4. Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
  5. Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)

  6. 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.
  7. Consumption of ethanol immediately prior to the research PSG
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
115 participants (actual)

Study arms

  • Experimental
    CPAP Device

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

    Device: Analysis with AED and manual PSG scoring

Interventions

  • DeviceAnalysis with AED and manual PSG scoring

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: one night

Secondary outcomes

  1. 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.

    Time frame: one night

07

Results

Posted Jan 16, 2019

Participant flow

A total of 148 (PSGs and overnights with PAP therapy), collected from 115 unique participants, were included in this analysis.

Participant flow — Overall Study
MilestoneAll Participants
Started115
Completed115
Not completed0

Outcome measures

PrimaryApnea-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.

Time frame:
one night
Reported as:
Mean · events per hour
Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm
events per hourManual PSG ScoringAutomatic Event Detection
Apnea-hypopnea index5.6 ± 8.05.8 ± 6.3
Apnea index2.4 ± 4.83.2 ± 5.25
Hypopnea index3.2 ± 5.22.6 ± 2.3
Statistical analysis
  • Manual PSG Scoring vs Automatic Event Detection · Wilcoxon (Mann-Whitney) · p = 0.007
SecondaryMethodological 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.

Time frame:
one night
Reported as:
Number · coefficient
Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC)
coefficientCPAP Device Compared to Manual PSG Scoring
Apnea-Hypopnea Index0.789
Apnea Index0.825
Hypopnea Index0.350

Adverse events

Collected over one overnight visit. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CPAP Device0/115 (0%)0/115 (0%)0/115 (0%)

Baseline characteristics

\*In summarizing the age, BMI, and sex statistics, the 4 participants who completed both trials were only counted once.

Age, Continuous
Age, Continuous(years)CPAP Device
Mean49.5 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)CPAP Device
Female31
Male84
Region of Enrollment
Region of Enrollment(participants)CPAP Device
United States115
BMI
BMI(kg/m^2)CPAP Device
Mean36.2 ± 7.6
08

Study locations

1 site
  • Shands and UF Sleep Disorder Center
    Gainesville, Florida 32606, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00836758
Lead sponsor
Philips Respironics
Responsible party
Sponsor
First posted
Feb 4, 2009
Start date
Feb 2009
Primary completion
Aug 2009
Completion
Aug 2009
Results posted
Jan 16, 2019
Last update
Jan 16, 2019

Study contacts

Richard Berry, MD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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