NCT01175031

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

May 2, 2016

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

July 30, 2010

Results QC Date

October 29, 2015

Last Update Submit

October 2, 2018

Conditions

Sleep Apnea CentralCheyne-Stokes RespirationObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography

    The following breathing events: RERAs, central apneas, periodic breathing, obstructive apneas, and hypopneas in patients previously diagnosed with CompSAS or OSA detected by simultaneous Polysomnography and REMstar Auto with A-Flex were compared.

    During a single night of polysomnography lasting an average of 8 hours

Secondary Outcomes (3)

  • Device Detected Apneas as Detected by Philips Respironics (PR) System One

    During a single night of polysomnography lasting an average of 8 hours

  • Device-Detected Obstructed Airway Apnea Agreement

    During a single night of polysomnography lasting an average of 8 hours

  • Device-Detected Clear Airway Apnea Agreement

    During a single night of polysomnography lasting an average of 8 hours

Study Arms (2)

REMstar Auto with A-Flex

EXPERIMENTAL

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.

Other: Manipulation of Positive Airway Pressure (PAP)

Manually Scored Polysomnography (PSG)

OTHER

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).

Other: Manipulation of Positive Airway Pressure (PAP)

Interventions

Manipulation of Positive Airway Pressure (PAP)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)REMstar Auto with A-Flex

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Florida - Shands Sleep Disorders Center

Gainesville, Florida, 32606, United States

Location

Sleep Health

Portage, Michigan, 49024, United States

Location

MeSH Terms

Conditions

Sleep Apnea, CentralCheyne-Stokes RespirationSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Quing Yun Li, MD, PhD
Organization
Shanghai Jiao Tong University School of Medicine
liqingyun68@hotmail.com
86-21-64314162

Study Officials

  • Richard Berry, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Sheila Tsai, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 4, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

October 31, 2018

Results First Posted

May 2, 2016

Record last verified: 2018-10

Locations

US(3)