Obstructive Sleep ApneaNCT00636181
Positive Pressure Treatment of Obstructive Sleep Apnea
A study testing Auto AFlex, Auto CPAP and CPAP in people with Obstructive Sleep Apnea, run by Philips Respironics at 5 sites in 2 countries.
Trial summary
Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes? Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Auto AFlex, Auto CPAP and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2008to Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21 - 75
- Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep
- Able and willing to provide written informed consent
- Agreement to try PAP (positive airway pressure) as initial treatment approach
- Adequate clinical CPAP titration within two weeks of enrollment
Who cannot join
- Participation in another interventional research study within the last 30 days
- The need for more than one titration PSG (polysomnography)
- The use of sedatives or hypnotics during the titration PSG
- Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment.
- Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.)
- Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation < or equal to 88% for more than five minutes).
Show all 15Show fewer
- 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:
- moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals)
- Restless Leg syndrome (greater than 10 per hour)
- Males experiencing chronic insomnia
- Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week.
- Consumption of ethanol more than 4 nights per week (CAGE criteria)
- Shift workers
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Sleep Disorders Center of Alabama
Birmingham, Alabama, 35213
University of Florida
Gainesville, Florida, 32608
Gaylord Hospital
New Haven, Connecticut, 06472
Stanford University
Stanford, California, 94304
About this study
Official title: Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes
Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
Read the detailed description
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Auto AFlex, Auto CPAP, CPAP
- 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.
Auto AFlexDevice
Positive pressure therapy treatment
Auto CPAPDevice
Positive pressure therapy treatment
CPAPDevice
Positive pressure therapy treatment
| Study group | Role | What they receive |
|---|---|---|
| Auto Aflex | Active comparator | auto adjusting positive pressure therapy with AFLEX Receives: Device: Auto AFlex |
| Auto CPAP | Active comparator | auto adjusting positive pressure therapy Receives: Device: Auto CPAP |
| CPAP | Active comparator | continuous positive airway pressure Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index
The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days
Measured: Baseline and 180 Days
Secondary outcomes (6)
Average Hours of Nightly Use.
The average hours of nightly use is the average number of hours the participant used there device overnight at home during the study.
Measured: 180 days
Psychomotor Vigilance Task - Number of Lapses
Psychomotor Vigilance Task-PVT is a 10-min attention/vigilance test. To measure trends of vigilance after 180 days of home use randomized sleep apnea trial. This measured how quickly participants reacted to visual stimulus and counted number of lapses.
Lapses (errors of omission) are measured or usually defined as reaction Times ≥ 500 ms.
Measured: Baseline and 180 Days
Functional Outcomes of Sleep Questionnaire (FOSQ)
FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships \& sexual activity (4 questions).
Scores are provided on a 0 to 4 scale:
0- I don't do this activity for other reasons or missing response
1- Yes, extreme difficulty 4- no difficulty
The average score was calculated based upon average sub-scores. The total score was,calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired.
Measured: Baseline and 180 Days
Attitudes Toward Use
Attitudes Toward Use Questionnaire (ATUQ) a self-efficacy scale based on psychological theories of behavior change and modified from one developed by Stepnowsky and Marler this outcome focused on confidence, expectations and importance.
Confidence is a 5 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The scores range from 5 to 25 with 25 being extremely confident.
Importance is a 11 question survey, it is measured on a scale of 1 to 5 1- disagree completely and 5 being agree completely. The importance ATU was combined with Exceptions survey, which is 4 questions. The expectations survey is measured on a scale of 1 to 5, with 1 being not at all effective and 5 extremely effective. The scores range from 15 to 75 with 75 being extremely important/ extremely effective.
Measured: Baseline and 180 Days
Subjective Assessment of Therapy Comfort.
visual analog scales where used to assess the question "in the last month how do you rate the overall comfort of the mask"?
0 = very uncomfortable to 100 = very comfortable
Measured: 30, 90, and 180 days
Epworth Sleepiness Scale
Epworth Sleepiness Scale is a test that measures sleepiness during daily life activities. This is an 8 question survey.
Scores are provided on a 0 to 3 scale:
0 = no chance of dozing
- = slight chance of dozing
- = moderate chance of dozing
- = high chance of dozing
Scores range from 0 to 24. The higher the total number, the higher the overall sleepiness.
Measured: Baseline and 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Clete Kushida, Stanford University
- Investigators
- Clete A. Kushida, M.D.; Ph.D;, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636181
- Sponsor's protocol ID
- CTG3
- Status last verified
- Jul 2019
- First submitted
- 6 Feb 2008
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Aloia MS, Stanchina M, Arnedt JT, Malhotra A, Millman RP. Treatment adherence and outcomes in flexible vs standard continuous positive airway pressure therapy. Chest. 2005 Jun;127(6):2085-93. doi: 10.1378/chest.127.6.2085.
PubMed 15947324Kushida CA, Berry RB, Blau A, Crabtree T, Fietze I, Kryger MH, Kuna ST, Pegram GV Jr, Penzel T. Positive airway pressure initiation: a randomized controlled trial to assess the impact of therapy mode and titration process on efficacy, adherence, and outcomes. Sleep. 2011 Aug 1;34(8):1083-92. doi: 10.5665/SLEEP.1166.
PubMed 21804670
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes
- ClinicalTrials.gov ID
- NCT00636181
- Acronym / sponsor ID
- CTG3
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Mar 2008 (estimated)
- Results
- Posted 13 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
Detailed description
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Auto Aflex | Active comparator | Device: Auto AFlexauto adjusting positive pressure therapy with AFLEX |
| Auto CPAP | Active comparator | Device: Auto CPAPauto adjusting positive pressure therapy |
| CPAP | Active comparator | Device: CPAPcontinuous positive airway pressure |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 - 75
- Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep
- Able and willing to provide written informed consent
- Agreement to try PAP (positive airway pressure) as initial treatment approach
- Adequate clinical CPAP titration within two weeks of enrollment
Key exclusion criteria (15 listed)
- Participation in another interventional research study within the last 30 days
- The need for more than one titration PSG (polysomnography)
- The use of sedatives or hypnotics during the titration PSG
- Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment.
- Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.)
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 |
|---|---|---|
| Auto AFlexPositive pressure therapy treatment | Device | Auto Aflex |
| Auto CPAPPositive pressure therapy treatment | Device | Auto CPAP |
| CPAPPositive pressure therapy treatment | Device | CPAP |
Primary outcome
Apnea-Hypopnea Index
Time frame: Baseline and 180 Days
The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days
6 secondary outcomes
Average Hours of Nightly Use.
Time frame: 180 days
Psychomotor Vigilance Task - Number of Lapses
Time frame: Baseline and 180 Days
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: Baseline and 180 Days
Attitudes Toward Use
Time frame: Baseline and 180 Days
Subjective Assessment of Therapy Comfort.
Time frame: 30, 90, and 180 days
Epworth Sleepiness Scale
Time frame: Baseline and 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15947324Aloia MS, Stanchina M, Arnedt JT, Malhotra A, Millman RP. Treatment adherence and outcomes in flexible vs standard continuous positive airway pressure therapy. Chest. 2005 Jun;127(6):2085-93. doi: 10.1378/chest.127.6.2085.
- Derived from this study: PubMed 21804670Kushida CA, Berry RB, Blau A, Crabtree T, Fietze I, Kryger MH, Kuna ST, Pegram GV Jr, Penzel T. Positive airway pressure initiation: a randomized controlled trial to assess the impact of therapy mode and titration process on efficacy, adherence, and outcomes. Sleep. 2011 Aug 1;34(8):1083-92. doi: 10.5665/SLEEP.1166.
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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.
Clete A. Kushida, M.D.; Ph.D; principal investigator
Stanford University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto AFlex, Auto CPAP and CPAP in people with Obstructive Sleep Apnea, run by Philips Respironics at 5 sites in 2 countries.
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 15 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 13 Aug 2019. 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, Germany. 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 13 Aug 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 Index (time frame: Baseline and 180 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636181, which also lists 2 linked publications.
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 13 Aug 2019.