Sleep Apnea
Conditions
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.
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.
Sponsors
Philips Respironics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm | one night | 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
| Measure | Time frame | Description |
|---|---|---|
| Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC) | one night | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 148 (PSGs and overnights with PAP therapy), collected from 115 unique participants, were included in this analysis.
Pre-assignment details
119 studies had a technically adequate recording and were collected from 90 patients (29 patients participated in two studies). These 119 studies were pooled with another 29 studies from another trial for a total of 148 studies. 4 patients participated in both trials and 3 of these patients contributed two recordings.
Participants by arm
| Arm | Count |
|---|---|
| CPAP Device Breathing event detection (AED) by the continuous positive airway pressure (CPAP) device will be compared to breathing event detection by a simultaneous PSG (manual PSG scoring).
Analysis 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. | 115 |
| Total | 115 |
Baseline characteristics
| Characteristic | CPAP Device |
|---|---|
| Age, Continuous | 49.5 years STANDARD_DEVIATION 11.3 |
| BMI | 36.2 kg/m^2 STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 115 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 115 |
| other Total, other adverse events | 0 / 115 |
| serious Total, serious adverse events | 0 / 115 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Manual PSG Scoring | Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm | Apnea-hypopnea index | 5.6 events per hour | Standard Deviation 8 |
| Manual PSG Scoring | Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm | Apnea index | 2.4 events per hour | Standard Deviation 4.8 |
| Manual PSG Scoring | Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm | Hypopnea index | 3.2 events per hour | Standard Deviation 5.2 |
| Automatic Event Detection | Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm | Apnea-hypopnea index | 5.8 events per hour | Standard Deviation 6.3 |
| Automatic Event Detection | Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm | Apnea index | 3.2 events per hour | Standard Deviation 5.25 |
| Automatic Event Detection | Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm | Hypopnea index | 2.6 events per hour | Standard Deviation 2.3 |
p-value: 0.007Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Manual PSG Scoring | Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC) | Apnea-Hypopnea Index | 0.789 coefficient |
| Manual PSG Scoring | Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC) | Apnea Index | 0.825 coefficient |
| Manual PSG Scoring | Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC) | Hypopnea Index | 0.350 coefficient |