Sleep ApneaNCT00836758
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
A study testing Analysis with AED and manual PSG scoring in people with Sleep Apnea, run by Philips Respironics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Analysis with AED and manual PSG scoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2009
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Shands and UF Sleep Disorder Center
Gainesville, Florida, 32606
About this study
Official title: Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography
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.
Read the detailed description
Purpose: The purpose of this study was to compare the AED algorithm used in a PAP device with manually scored events on PSG. The PAP device was modified to produce a square wave voltage output identifying when apneas, hypopneas, and snoring events were detected. Recording this event signal on the PSG performed with the patient using the PAP device allowed an event-by-event comparison between manually scored PSG events and AED events. In addition, the AHI, AI, and HI derived from the manually scored PSG were compared with the respective measures reported by the PAP device used during the PSG.
Study Objectives: Compare automatic event detection (AED) of respiratory events using a positive airway pressure (PAP) device with manual scoring of polysomnography (PSG) during PAP treatment of obstructive sleep apnea (OSA).
Design: Prospective PSGs of patients using a PAP device.
Setting: Six academic and private sleep disorders centers.
Interventions: A signal generated by the PAP device identifying the AED of respiratory events based on airflow was recorded during PSG.
- Conditions
- Sleep Apnea
- Being tested
- Analysis with AED and manual PSG scoring
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis with AED and manual PSG scoringDevice
The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring.
| Study group | Role | What they receive |
|---|---|---|
| CPAP Device | Experimental | Breathing event detection (AED) by the CPAP device will be compared to breathing event detection by a simultaneous PSG (manual PSG scoring). Receives: Device: Analysis with AED and manual PSG scoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm
Apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. The Apnea index (AI) is the average number of apneas that occur per hour of sleep. The Hypopnea index (HI) is the average number of hypopneas that occur per hour of sleep.
The PSGs were manually scored to determine the apnea-hypopnea index. This value was then compared to the PAP device which utilized the AED algorithm to determine the apnea-hypopnea index.
Measured: one night
Secondary outcomes (1)
Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC)
Methodological comparisons utilizing ICC for detection of AHI, apnea index (AI) and hypopnea index (HI) were caculated between the values obtained by PSG and the REMstar Auto with A-Flex device.
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionAug 2009
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 ApneaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants wore a PAP device and had a PSG at the same time. These participants had their PSG data compared to the PAP data.
- Masking
- None (open label)
- Enrolment
- 115 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 Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836758
- Sponsor's protocol ID
- EDILP-2008-SST-01
- Status last verified
- Dec 2018
- First submitted
- 3 Feb 2009
- Last updated
- 16 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography
- ClinicalTrials.gov ID
- NCT00836758
- Acronym / sponsor ID
- EDILP-2008-SST-01
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 16 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose: The purpose of this study was to compare the AED algorithm used in a PAP device with manually scored events on PSG. The PAP device was modified to produce a square wave voltage output identifying when apneas, hypopneas, and snoring events were detected. Recording this event signal on the PSG performed with the patient using the PAP device allowed an event-by-event comparison between manually scored PSG events and AED events. In addition, the AHI, AI, and HI derived from the manually scored PSG were compared with the respective measures reported by the PAP device used during the PSG.
Study Objectives: Compare automatic event detection (AED) of respiratory events using a positive airway pressure (PAP) device with manual scoring of polysomnography (PSG) during PAP treatment of obstructive sleep apnea (OSA).
Design: Prospective PSGs of patients using a PAP device.
Setting: Six academic and private sleep disorders centers.
Interventions: A signal generated by the PAP device identifying the AED of respiratory events based on airflow was recorded during PSG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants wore a PAP device and had a PSG at the same time. These participants had their PSG data compared to the PAP data.
| Arm | Type | Receives |
|---|---|---|
| CPAP Device | Experimental | Device: Analysis with AED and manual PSG scoringBreathing event detection (AED) by the CPAP device will be compared to breathing event detection by a simultaneous PSG (manual PSG scoring). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| Analysis with AED and manual PSG scoringThe CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring. | Device | CPAP Device |
Primary outcome
Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm
Time frame: one night
Apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. The Apnea index (AI) is the average number of apneas that occur per hour of sleep. The Hypopnea index (HI) is the average number of hypopneas that occur per hour of sleep. The PSGs were manually scored to determine the apnea-hypopnea index. This value was then compared to the PAP device which utilized the AED algorithm to determine the apnea-hypopnea index.
1 secondary outcome
Methodological Comparisons of AHI, Apnea Index (AI) and Hypopnea Index (HI) as Determined by Intra-class Correlation (ICC)
Time frame: one night
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis with AED and manual PSG scoring in people with Sleep Apnea, run by Philips Respironics at 1 site 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 5 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 16 Jan 2019). 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?
Apnea-hypopnea Indices (AHI) as Determined by Polysomnography (PSG) vs Automatic Event Detection (AED ) Algorithm (time frame: one night). 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 16 Jan 2019.