Obstructive Sleep ApneaNCT01831258
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
A study testing SensAwake On and SensAwake Off in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 3 sites in United States.
Trial summary
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- SensAwake On and SensAwake Off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to Sep 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).
- Successful in-lab titration polysomnography (PSG)
- General (at home) sleep habits of:
- At least 7 hours in bed on most nights
- Lights out at 12 midnight or earlier
- Fluency in both written and spoken English.
Who cannot join
- Participants prescribed and fitted with any PAP device in the past 2 years
- Contraindicated for CPAP or AutoCPAP therapy.
- Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
- Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
- Patients who are prescribed hypnotics and sedating medications.
- Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months.
- If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
- If the physician objects to their patient taking part in the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Sleep Med of South Carolina
Columbia, South Carolina
Pulmonary Associates
Glendale, Arizona, 85306
SleepMed of Central Georgia
Macon, Georgia
About this study
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \& Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.
The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology.
It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- SensAwake On, SensAwake Off
- 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.
SensAwake OnDevice
SensAwake OffDevice
| Study group | Role | What they receive |
|---|---|---|
| SensAwake On | Experimental | The comfort feature 'SensAwake' will be turned on Receives: Device: SensAwake On |
| SensAwake Off | Active comparator | The comfort feature 'SensAwake' will be turned off Receives: Device: SensAwake Off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to CPAP Treatment
Average used minutes (all days) taken from the CPAP device.
Measured: 2 weeks
Secondary outcomes (6)
Daytime Sleepiness (Subjective Sleep Quality)
Collected through the Epworth Sleepiness Scale (ESS) which is a subjective questionnaire and the participant answer 8 question with rating on the chance of dozing (from 0= no chance of dozing to 3 = high chance of dozing). The total is added with a range from 0-24. A total score of 0 means that the participant is not experiencing day time sleepiness, while total score of 24 means that the participant si extremely sleepy during the daytime.
Measured: 4 weeks
Insomnia Severity Index (Subjective Sleep Quality)
Collected through the Insomnia Severity Index (ISI). There are seven question with each question having a scale of 0 (no issue) to 4 (very severe). The total score is added up. If the participant has a total score of 0-7 = no clinical significant insomnia, total score of 8-14 = sub threshold insomnia, total score of 15-21 = clinical insomnia (moderate), total score of 22-28 = clinical insomnia (severe).
Measured: 4 weeks
OSA Impact of Daily Life
Collected through the Short Functional Outcomes of Sleep Questionnaire (FOSQ-10). The questionnaire has 10 questions which ask how daytime sleepiness has impacted their quality of life. Each question has a scale of 1 = yes extreme to 4 = No. Lower total score (min 10) means that the disease is affecting your quality of life while a higher total score (maximum 40) means that the disease is not affecting your quality of life.
Measured: 4 weeks
OSA Impact of Daily Life (Fatigue)
Collected through the Fatigue Severity Scale (FSS). There are 9 question on fatigue with each question having a scale of 1 = strongly disagree and 7 = strongly agree. A lower total score (minimum of 9) = low severity with fatigue while a higher total score (maximum of 63) indicates a higher severity with fatigue.
Measured: 4 weeks
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity
Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the chance (if any) in symptoms related to your OSA. The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.
Measured: 4 weeks
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change
Collected through the Patient Global Impression of Change (PGI).The questions ask "Since beginning CPAP therapy, how would you describe the change (if any) in overall quality of life related to your OSA?". The questions has a scale of 1 = no change (or condition has got worse) to 7 = a great deal better and a considerable improvement that has made all the difference.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionSep 2014
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.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831258
- Sponsor's protocol ID
- FPH-SA13-01
- Status last verified
- Jun 2017
- First submitted
- 2 Apr 2013
- Last updated
- 19 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
- ClinicalTrials.gov ID
- NCT01831258
- Acronym / sponsor ID
- FPH-SA13-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Posted 19 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \& Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep.
The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology.
It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SensAwake On | Experimental | Device: SensAwake OnThe comfort feature 'SensAwake' will be turned on |
| SensAwake Off | Active comparator | Device: SensAwake OffThe comfort feature 'SensAwake' will be turned off |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).
- Successful in-lab titration polysomnography (PSG)
- General (at home) sleep habits of:
- At least 7 hours in bed on most nights
- Lights out at 12 midnight or earlier
Key exclusion criteria (8 listed)
- Participants prescribed and fitted with any PAP device in the past 2 years
- Contraindicated for CPAP or AutoCPAP therapy.
- Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
- Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
- Patients who are prescribed hypnotics and sedating medications.
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 |
|---|---|---|
| SensAwake On | Device | SensAwake On |
| SensAwake Off | Device | SensAwake Off |
Primary outcome
Adherence to CPAP Treatment
Time frame: 2 weeks
Average used minutes (all days) taken from the CPAP device.
6 secondary outcomes
Daytime Sleepiness (Subjective Sleep Quality)
Time frame: 4 weeks
Insomnia Severity Index (Subjective Sleep Quality)
Time frame: 4 weeks
OSA Impact of Daily Life
Time frame: 4 weeks
OSA Impact of Daily Life (Fatigue)
Time frame: 4 weeks
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity
Time frame: 4 weeks
Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Change
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SensAwake On and SensAwake Off in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare 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 6 inclusion and 8 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 19 Jul 2017. 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 19 Jul 2017). 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?
Adherence to CPAP Treatment (time frame: 2 weeks). 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 19 Jul 2017.