N/A
N=115
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT00836758 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm — 5.6; 5.8; 2.4; 3.2 events per hour — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Analysis with AED and manual PSG scoring (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Philips Respironics
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm |
5.6; 5.8; 2.4; 3.2; 3.2; 2.6 | 0.007 sig |
| SECONDARY Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC) |
0.789; 0.825; 0.350 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00836758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.