Obstructive Sleep ApneaNCT01450540
Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients
A study testing REMstar Auto A-Flex and modified REMstar Auto A-Flex with AGPAP in people with Obstructive Sleep Apnea, run by Philips Respironics at 5 sites in United States.
Trial summary
Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extended duration ramp, where the patient receives pressure below their prescription during an acclimation phase. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- REMstar Auto A-Flex and modified REMstar Auto A-Flex with AGPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2011to Apr 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed with OSA (last 12 weeks)
- Prescribed continuous positive airway pressure (CPAP) pressure ≥ 10 cmH2O
- Willing and able to provide informed consent
- Able to follow instructions
Who cannot join
- Participation in another interventional research study within the last 30 days
- Major controlled or an uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)
- Prior PAP prescription, use, or any prior OSA treatment, excluding split-night or titration PAP exposure.
- Prescribed BiLevel therapy
- Presence of untreated, non-OSA related sleep disorders (e.g. moderate to severe restless legs (PLMAI ≥ 20) or insomnia)
- History of an automobile accident or near accident in the last 12 months due to sleepiness.
Show all 12Show fewer
- Severe oxygen desaturation on the PSG (Sa02 < 70% for 10% of the diagnostic PSG study).
- Surgery of the upper airway, nose, sinus, or middle ear within the past 90 days
- Regular use (>3 nights per week) of sleeping pills or stimulants.
- Currently working a night shift or rotating day/night shift.
- Unwillingness to try PAP at home.
- Presence of tracheostomy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Sleep Disorders Center of Georgia
Atlanta, Georgia, 30342
Delta Waves Sleep Disorder and Research Center
Colorado Springs, Colorado, 80918
Clinilabs, Inc.
New York, New York, 10019
Sleep Therapy and Research Center
San Antonio, Texas, 78229
Clayton Sleep Institute
St Louis, Missouri, 63143
About this study
Official title: Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed OSA Patients: Multicenter Trial
Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extended duration ramp, where the patient receives pressure below their prescription during an acclimation phase. The algorithm gradually increases pressure to therapy level based on usage. The aim of this study was to determine the effectiveness of the AGPAP acclimation period and its impact on short term adherence.
Read the detailed description
Even though CPAP is highly effective in treating sleep apnea, adherence to CPAP therapy remains the largest single obstacle to the successful resolution of sleep-disordered breathing in OSA patients. It has been estimated that up to 50% of patients who have been prescribed CPAP for Obstructive Sleep Apnea (OSA) are not using the treatment one year later. A myriad of possible causes for low compliance rates have been proposed and examined in previous studies. These include race, gender, education level, income, bed-partner's sleep quality, mask discomfort, continuity of care, nasal irritation, discomfort due to elevated expiratory pressure, and level of daytime sleepiness.
Therefore, many investigators have proposed new methods and approaches to help deal with these problems. Interventions have ranged from people-centric approaches using intensive CPAP education and follow-up programs, to device modifications using features such as a ramp, C-FLEX®, BiLevel therapy, and heated humidification.
In this study. The aim of this study was to determine the effectiveness of the Automated Graduated CPAP (AGPAP), also know as EZ-start acclimation period, and its impact on short term adherence
- Conditions
- Obstructive Sleep Apnea
- Being tested
- REMstar Auto A-Flex, modified REMstar Auto A-Flex with AGPAP
- 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.
REMstar Auto A-FlexDevice
Also called Philips Respironics System One
Standard CPAP
modified REMstar Auto A-Flex with AGPAPDevice
Also called Philips Respironics System One
Modified device -Software upgrade to GP 12
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | REMStar auto A-Flex Receives: Device: REMstar Auto A-Flex |
| Group 2 | Experimental | modified REMstar Auto A-Flex with AGPAP Receives: Device: modified REMstar Auto A-Flex with AGPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP Adherence
Device usage (hours per night)
Measured: 3 months
Secondary outcomes (2)
Functional Outcome Sleep Quality (FOSQ)
Functional Outcomes Sleep Questionnaire (FOSQ) is a self-administered instrument designed to assess the impact of excessive sleepiness on daytime function and to quantify improvement after treatment. It contains 30 items divided into 5 subscales: Activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcome. The patient rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty) A mean score is calculated for each scale ranging from 0 (maximum functional impact) to 24 (no functional impact).
Measured: 3 months
Daytime Sleepiness as Measured by the Epworth Sleepiness Scale
Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score can range from 0 to 24. The higher the ESS score, the higher is the overall 'daytime sleepiness'.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionApr 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 Obstructive 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan Lankford, PhD, Principal investigator, Sleep Disorders Center of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450540
- Sponsor's protocol ID
- AR-1112-AGPAP-MS
- Status last verified
- Feb 2021
- First submitted
- 7 Oct 2011
- Last updated
- 3 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed OSA Patients: Multicenter Trial
- ClinicalTrials.gov ID
- NCT01450540
- Acronym / sponsor ID
- AR-1112-AGPAP-MS
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Sep 2011 (actual)
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Posted 3 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extended duration ramp, where the patient receives pressure below their prescription during an acclimation phase. The algorithm gradually increases pressure to therapy level based on usage. The aim of this study was to determine the effectiveness of the AGPAP acclimation period and its impact on short term adherence.
Detailed description
Even though CPAP is highly effective in treating sleep apnea, adherence to CPAP therapy remains the largest single obstacle to the successful resolution of sleep-disordered breathing in OSA patients. It has been estimated that up to 50% of patients who have been prescribed CPAP for Obstructive Sleep Apnea (OSA) are not using the treatment one year later. A myriad of possible causes for low compliance rates have been proposed and examined in previous studies. These include race, gender, education level, income, bed-partner's sleep quality, mask discomfort, continuity of care, nasal irritation, discomfort due to elevated expiratory pressure, and level of daytime sleepiness.
Therefore, many investigators have proposed new methods and approaches to help deal with these problems. Interventions have ranged from people-centric approaches using intensive CPAP education and follow-up programs, to device modifications using features such as a ramp, C-FLEX®, BiLevel therapy, and heated humidification.
In this study. The aim of this study was to determine the effectiveness of the Automated Graduated CPAP (AGPAP), also know as EZ-start acclimation period, and its impact on short term adherence
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Device: REMstar Auto A-FlexREMStar auto A-Flex |
| Group 2 | Experimental | Device: modified REMstar Auto A-Flex with AGPAPmodified REMstar Auto A-Flex with AGPAP |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed with OSA (last 12 weeks)
- Prescribed continuous positive airway pressure (CPAP) pressure ≥ 10 cmH2O
- Willing and able to provide informed consent
- Able to follow instructions
Key exclusion criteria (12 listed)
- Participation in another interventional research study within the last 30 days
- Major controlled or an uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)
- Prior PAP prescription, use, or any prior OSA treatment, excluding split-night or titration PAP exposure.
- Prescribed BiLevel therapy
- Presence of untreated, non-OSA related sleep disorders (e.g. moderate to severe restless legs (PLMAI ≥ 20) or insomnia)
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 |
|---|---|---|
| REMstar Auto A-FlexAlso: Philips Respironics System OneStandard CPAP | Device | Group 1 |
| modified REMstar Auto A-Flex with AGPAPAlso: Philips Respironics System OneModified device -Software upgrade to GP 12 | Device | Group 2 |
Primary outcome
CPAP Adherence
Time frame: 3 months
Device usage (hours per night)
2 secondary outcomes
Functional Outcome Sleep Quality (FOSQ)
Time frame: 3 months
Daytime Sleepiness as Measured by the Epworth Sleepiness Scale
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- 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.
Alan Lankford, PhD principal investigator
Sleep Disorders Center of Georgia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REMstar Auto A-Flex and modified REMstar Auto A-Flex with AGPAP in people with Obstructive Sleep Apnea, run by Philips Respironics at 5 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 4 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 3 Mar 2021). 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?
CPAP Adherence (time frame: 3 months). 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 3 Mar 2021.