Sleep Apnea CentralNCT01175031
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
A study testing Manipulation of Positive Airway Pressure (PAP) in people with Sleep Apnea Central and Cheyne-Stokes Respiration, run by Philips Respironics at 3 sites in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Sleep Apnea Central, Cheyne-Stokes Respiration, Obstructive Sleep Apnea
- What is being tested?
- Manipulation of Positive Airway Pressure (PAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2010to Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Jewish Health
Denver, Colorado, 80206
University of Florida - Shands Sleep Disorders Center
Gainesville, Florida, 32606
Sleep Health
Portage, Michigan, 49024
About this study
Official title: Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography
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).
Read the 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.
- Being tested
- Manipulation of Positive Airway Pressure (PAP)
- Medical subject headings
- Sleep Apnea, Central, Cheyne-Stokes Respiration, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Manipulation of Positive Airway Pressure (PAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
All device-detected apneas were tabulated. Then they were broken down into obstructed airway apneas and clear airway apneas. The results are recorded below as apneas with obstructed airway and apneas with clear airway.
Measured: During a single night of polysomnography lasting an average of 8 hours
Device-Detected Obstructed Airway Apnea Agreement
Device-Detected Apneas were broken down and then reviewed with the manually scored apneas. Of the Obstructed Airway apneas they were broken down into a few different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually Scored Hypopneas and Manually Scored RERAs.
Measured: During a single night of polysomnography lasting an average of 8 hours
Device-Detected Clear Airway Apnea Agreement
Device Detected Clear Airways events were counted by the device. These events were then compared to manual PSG scoring. The manual PSG scoring determined that these were apnea events. However, the manual scoring allows for more channels to be reviewed and manual scoring was able to classify them into 4 different categories: Manually Scored Obstructive Apneas, Manually Scored Central Apneas, Manually scored hypopneas and manually scored RERAs.
Measured: During a single night of polysomnography lasting an average of 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea CentralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Berry, MD, Principal investigator, University of FloridaSheila Tsai, MD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01175031
- Sponsor's protocol ID
- ST-1002-PRS1ED-MS
- Status last verified
- Oct 2018
- First submitted
- 30 Jul 2010
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography
- ClinicalTrials.gov ID
- NCT01175031
- Acronym / sponsor ID
- ST-1002-PRS1ED-MS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Posted 2 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REMstar Auto with A-Flex | Experimental | Other: Manipulation of Positive Airway Pressure (PAP)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. |
| Manually Scored Polysomnography (PSG) | Other | Other: Manipulation of Positive Airway Pressure (PAP)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). |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Manually Scored Polysomnography (PSG), REMstar Auto with A-Flex |
Primary outcome
Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography
Time frame: During a single night of polysomnography lasting an average of 8 hours
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.
3 secondary outcomes
Device Detected Apneas as Detected by Philips Respironics (PR) System One
Time frame: During a single night of polysomnography lasting an average of 8 hours
Device-Detected Obstructed Airway Apnea Agreement
Time frame: During a single night of polysomnography lasting an average of 8 hours
Device-Detected Clear Airway Apnea Agreement
Time frame: During a single night of polysomnography lasting an average of 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Berry, MD principal investigator
University of Florida
Sheila Tsai, MD principal investigator
National Jewish Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation of Positive Airway Pressure (PAP) in people with Sleep Apnea Central and Cheyne-Stokes Respiration, run by Philips Respironics at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Breathing Events Identified by the Continuous Positive Airway Pressure (CPAP) Device Compared to a Simultaneous Polysomnography (time frame: During a single night of polysomnography lasting an average of 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2018.