Sleep Apnea, ObstructivePBSWNCT01031914
Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)
A study testing Paced Breathing in people with Sleep Apnea, Obstructive, run by Philips Respironics at 1 site in United States.
Trial summary
The purpose of this engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Paced Breathing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2010
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21-70
- Diagnosis of obstructive sleep apnea (OSA)
- Current adherent CPAP user (has been using CPAP nightly for at least 2 weeks).
- On CPAP pressures of 5-10cm.
- Subjects wishing to complete a day or evening appointment need to have significant daytime sleepiness (Epworth Sleepiness Scale score of 8 or above)
- Able and willing to provide written informed consent
- English speaking
Who cannot join
- Participation in another interventional research study within the last 30 days
- Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure etc.
- Inability to tolerate nasal CPAP mask due to problems breathing solely through their nose.
- Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake (PaCo2≥55mmHg)
- Severe oxygen desaturation on the polysomnography (PSG), i.e. Sa02 < 70% for 10% of the study.
- Surgery of the upper airway, nose, sinus or middle ear within the past 90 days
Show all 12Show fewer
- Currently using supplemental oxygen
- Regular use of sleeping pills or stimulants (> 3 nights a week)
- Currently working night shift or rotating day/night shift
- Drowsy Driving or near miss accident in the past 6 months
- Inability to tolerate or track to Paced Breathing device during initial habituation session in lab
- Chronic insomnia, Restless legs syndrome, or severe periodic limb movement disorder (PLMD - PLMAI>20/hr).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure Users Using Paced Breathing
The purpose of this engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy. In this trial the investigators will be evaluating the algorithm's ability to correctly distinguish between sleep and wake.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Paced Breathing
- Keywords
- Paced Breathing, OSA, sleep/wake detection
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paced BreathingDevice
Also called Respironics
The Paced Breathing (PB) feature(when activated) will work to relax the user and help them fall asleep by encouraging them to take deep slow breaths until they reach 10 breaths (or less) per minute. The feature will also detect when the subject has fallen asleep so the Continuous Positive Airway Pressur (CPAP) device will automatically switch from PB mode to regular CPAP mode.
| Study group | Role | What they receive |
|---|---|---|
| Paced Breathing Sleep/Wake detection | Experimental | All subjects enrolled will have oobstructive sleep apnea (OSA) and will be current Continuous Positive Airway Pressur (CPAP) users. Receives: Device: Paced Breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep/Wake Algorithm
We tested the ability of the Sleep/Wake algorithm to identify sleep an wake periods with precision, as compared to standard polysonography (PSG) measures, which was used as the gold standard, i.e. we tested the accuracy of the algorithm. Accuracy was defined as the proportion of true results (both true positives and true negatives)in the population and it was assesed using as 2 X 2 table, i.e. accuracy = number of true positives + number of true negatives/ number of true positives + false positives + false negatives +true negatives. where True positive = the algorithm tested correctly identified sleep, False positive = the algorithm tested incorrectly identified sleep, True negative = the algorithm tested correctly rejected awake periods, and False negative = the algorithm tested incorrectly rejected awake periods.
Measured: The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startOct 2009
- Primary completionSep 2010
- Study completionSep 2010
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, ObstructiveStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David P White, M.D, Principal investigator, Philips Respironics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031914
- Sponsor's protocol ID
- AR-0931-PBSW-SS
- Acronym
- PBSW
- Status last verified
- Apr 2013
- First submitted
- 11 Dec 2009
- Last updated
- 14 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure Users Using Paced Breathing
- ClinicalTrials.gov ID
- NCT01031914
- Acronym / sponsor ID
- PBSW / AR-0931-PBSW-SS
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Paced Breathing, OSA, sleep/wake detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Dec 2009 (estimated)
- Results
- Posted 14 May 2013
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 engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy. In this trial the investigators will be evaluating the algorithm's ability to correctly distinguish between sleep and wake.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paced Breathing Sleep/Wake detection | Experimental | Device: Paced BreathingAll subjects enrolled will have oobstructive sleep apnea (OSA) and will be current Continuous Positive Airway Pressur (CPAP) users. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 21-70
- Diagnosis of obstructive sleep apnea (OSA)
- Current adherent CPAP user (has been using CPAP nightly for at least 2 weeks).
- On CPAP pressures of 5-10cm.
- Subjects wishing to complete a day or evening appointment need to have significant daytime sleepiness (Epworth Sleepiness Scale score of 8 or above)
Key exclusion criteria (12 listed)
- Participation in another interventional research study within the last 30 days
- Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure etc.
- Inability to tolerate nasal CPAP mask due to problems breathing solely through their nose.
- Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe chronic obstructive pulmonary disease (COPD), or any condition with an elevation of arterial carbon dioxide levels while awake (PaCo2≥55mmHg)
- Severe oxygen desaturation on the polysomnography (PSG), i.e. Sa02 < 70% for 10% of 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 |
|---|---|---|
| Paced BreathingAlso: RespironicsThe Paced Breathing (PB) feature(when activated) will work to relax the user and help them fall asleep by encouraging them to take deep slow breaths until they reach 10 breaths (or less) per minute. The feature will also detect when the subject has fallen asleep so the Continuous Positive Airway Pressur (CPAP) device will automatically switch from PB mode to regular CPAP mode. | Device | Paced Breathing Sleep/Wake detection |
Primary outcome
Sleep/Wake Algorithm
Time frame: The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 hours.
We tested the ability of the Sleep/Wake algorithm to identify sleep an wake periods with precision, as compared to standard polysonography (PSG) measures, which was used as the gold standard, i.e. we tested the accuracy of the algorithm. Accuracy was defined as the proportion of true results (both true positives and true negatives)in the population and it was assesed using as 2 X 2 table, i.e. accuracy = number of true positives + number of true negatives/ number of true positives + false positives + false negatives +true negatives. where True positive = the algorithm tested correctly identified sleep, False positive = the algorithm tested incorrectly identified sleep, True negative = the algorithm tested correctly rejected awake periods, and False negative = the algorithm tested incorrectly rejected awake periods.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
- 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.
David P White, M.D principal investigator
Philips Respironics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paced Breathing in people with Sleep Apnea, Obstructive, 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 7 inclusion and 12 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 14 May 2013. 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 14 May 2013). 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?
Sleep/Wake Algorithm (time frame: The performance of the algorithm will be evaluated in real time while the subject is wearing the device during the sleep study, an average of 08 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 14 May 2013.