Clinical trial NCT01175031: Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
Official title: Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Central
Cheyne-Stokes Respiration
Obstructive Sleep Apnea
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2010-08-04
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended clinical polysomnography (PSG) in identifying breathing events in participants previously diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes respiration (CSR), or obstructive sleep apnea (OSA).

Detailed description: Study Objectives: To compare a positive airway pressure (PAP) device's detection of respiratory events and airway status during device detected apneas with events scored on simultaneous polysomnography (PSG).

Design: Prospective PSGs of patients with sleep apnea using a new-generation PAP device.

Settings: Four clinical and academic sleep centers.

Patients: Forty-five patients with obstructive sleep apnea (OSA) and complex sleep apnea (Comp SA) performed a PSG on PAP levels adjusted to induce respiratory events.

Interventions: None.

Eligibility criteria: Inclusion Criteria:

* Males and females, ages 21-80.
* Able and willing to provide written informed consent.
* Diagnosis of complex sleep apnea (CompSAS) or Obstructive Sleep Apnea (OSA) within one year of study participation.
* For participants with CompSAS: (a) Diagnostic PSG with an Apnea-Hyopnea Index (AHI) greater than or equal to 10 events/hour and central apnea index (CAI) greater than or equal to 5 events/hour of sleep or (b) PAP titration with a CAI greater than or equal to 5 events/hour of sleep.
* For participants with OSA, a diagnostic PSG with an AHI greater than or equal to 15 events/hour of sleep.
* Must have had a CPAP titration such that the necessary PAP level to treat the sleep disordered breathing is known.
* Agreement to undergo a full-night, in-laboratory PSG on CPAP device.

Exclusion Criteria:

* Participation in an interventional research study within 30 days of study participation.
* Pre-menopausal females known to be pregnant or who are sexually active and not using a reliable method of birth control.
* Surgery of the upper airway, nose, sinus, or middle ear within the last 90 days.
* Surgery at any time for the treatment of OSA such as uvulopalatopharyngoplasty (UPPP).
* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to positive airway pressure, or the ability to complete the study.
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\> 45 mmHg) while awake.
* Currently prescribed oxygen therapy.
* Ventilatory induced barotrauma within 6 months of study participation.
* Untreated insomnia.
* Other major medical condition that, in the judgment of the investigator, precludes participation in this study.

Primary outcomes:
measure: Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography
timeFrame: During a single night of polysomnography lasting an average of 8 hours
Secondary outcomes:
measure: Device Detected Apneas as Detected by Philips Respironics (PR) System One
timeFrame: During a single night of polysomnography lasting an average of 8 hours
measure: Device-Detected Obstructed Airway Apnea Agreement
timeFrame: During a single night of polysomnography lasting an average of 8 hours
measure: Device-Detected Clear Airway Apnea Agreement
timeFrame: During a single night of polysomnography lasting an average of 8 hours
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Gainesville
country: United States
facility: University of Florida - Shands Sleep Disorders Center
state: Florida
city: Portage
country: United States
facility: Sleep Health
state: Michigan
Study officials:
affiliation: University of Florida
name: Richard Berry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Jewish Health
name: Sheila Tsai, MD
role: PRINCIPAL_INVESTIGATOR
References: