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

NCT ID: NCT01175031

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-09-30

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.

Conditions

Sleep Apnea Central; Cheyne-Stokes Respiration; Obstructive Sleep Apnea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

REMstar Auto with A-Flex

Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex.

Group Type: EXPERIMENTAL

Manipulation of Positive Airway Pressure (PAP)

Intervention Type: OTHER

Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.

Manually Scored Polysomnography (PSG)

Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be Manually Scored Polysomnography (PSG).

Group Type: OTHER

Manipulation of Positive Airway Pressure (PAP)

Intervention Type: OTHER

Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.

Interventions

Manipulation of Positive Airway Pressure (PAP)

Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Respironics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Berry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Sheila Tsai, MD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Health

Denver, Colorado, United States

University of Florida - Shands Sleep Disorders Center

Gainesville, Florida, United States

Sleep Health

Portage, Michigan, United States

Countries

United States

Other Identifiers

ST-1002-PRS1ED-MS

Identifier Type: -

Identifier Source: org_study_id