Obstructive Sleep ApneaNCT02971436
Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
A study testing FPH Device with SensAwake On + Pressure Support A, FPH Device with SensAwake Off + Pressure Support A and FPH Device with SensAwake On + Pressure Support B in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 2 sites in New Zealand.
Trial summary
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- FPH Device with SensAwake On + Pressure Support A, FPH Device with SensAwake Off + Pressure Support A and FPH Device with SensAwake On + Pressure Support B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Dec 2016to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and over
- Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP.
- For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator)
Who cannot join
- Contraindicated for PAP (CPAP or AutoCPAP) therapy
- Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
- Persons with obesity hypoventilation syndrome or congestive heart failure.
- Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device
- Persons with implanted electronic medical device (e.g cardiac pacemakers)
- Persons who are pregnant or think they might be pregnant.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Fisher & Paykel Healthcare
Auckland, 0600
WellSleep Centre
Wellington, 6035
About this study
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- FPH Device with SensAwake On + Pressure Support A, FPH Device with SensAwake Off + Pressure Support A, FPH Device with SensAwake On + Pressure Support B, FPH Device with SensAwake Off + Pressure Support B, Competitor's PAP Released Device + Pressure Support A
- 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.
FPH Device with SensAwake On + Pressure Support ADevice
FPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake Off + Pressure Support ADevice
FPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake On + Pressure Support BDevice
FPH Device with SensAwake On + Pressure Support B
FPH Device with SensAwake Off + Pressure Support BDevice
FPH Device with SensAwake Off + Pressure Support B
Competitor's PAP Released Device + Pressure Support ADevice
Competitor's PAP Released Device + Pressure Support A
Competitor's PAP Released Device + Pressure Support BDevice
Competitor's PAP Released Device + Pressure Support B
| Study group | Role | What they receive |
|---|---|---|
| FPH Device with SensAwake On + Pressure Support A | Active comparator | FPH Device with SensAwake On + Pressure Support A Receives: Device: FPH Device with SensAwake On + Pressure Support A |
| FPH Device with SensAwake Off + Pressure Support A | Active comparator | FPH Device with SensAwake Off + Pressure Support A Receives: Device: FPH Device with SensAwake Off + Pressure Support A |
| FPH Device with SensAwake On + Pressure Support B | Active comparator | FPH Device with SensAwake On + Pressure Support B Receives: Device: FPH Device with SensAwake On + Pressure Support B |
| FPH Device with SensAwake Off + Pressure Support B | Active comparator | FPH Device with SensAwake Off + Pressure Support B Receives: Device: FPH Device with SensAwake Off + Pressure Support B |
| Competitor's PAP Released Device + Pressure Support A | Active comparator | Competitor's PAP Released Device + Pressure Support A Receives: Device: Competitor's PAP Released Device + Pressure Support A |
| Competitor's PAP Released Device + Pressure Support B | Active comparator | Competitor's PAP Released Device + Pressure Support B Receives: Device: Competitor's PAP Released Device + Pressure Support B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
Through the device and independent flow logger
Measured: 3 nights
Apnea Hypopnea Index (AHI)
Through the polysomnography
Measured: 1 night
Secondary outcomes (4)
Therapy Comfort
Through a subjective questionnaire
Measured: 3 nights
Compliance
Through the device and independent flow logger
Measured: 3 nights
Device Triggering
Through the device
Measured: 3 nights
Device Triggering
Through the polysomnography
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study startDec 2016
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Why it stopped: project progression decision was able to be made with the data already gathered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 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
- NCT02971436
- Sponsor's protocol ID
- CIA196
- Status last verified
- Aug 2018
- First submitted
- 17 Nov 2016
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02971436
- Acronym / sponsor ID
- CIA196
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: project progression decision was able to be made with the data already gathered
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| FPH Device with SensAwake On + Pressure Support A | Active comparator | Device: FPH Device with SensAwake On + Pressure Support AFPH Device with SensAwake On + Pressure Support A |
| FPH Device with SensAwake Off + Pressure Support A | Active comparator | Device: FPH Device with SensAwake Off + Pressure Support AFPH Device with SensAwake Off + Pressure Support A |
| FPH Device with SensAwake On + Pressure Support B | Active comparator | Device: FPH Device with SensAwake On + Pressure Support BFPH Device with SensAwake On + Pressure Support B |
| FPH Device with SensAwake Off + Pressure Support B | Active comparator | Device: FPH Device with SensAwake Off + Pressure Support BFPH Device with SensAwake Off + Pressure Support B |
| Competitor's PAP Released Device + Pressure Support A | Active comparator | Device: Competitor's PAP Released Device + Pressure Support ACompetitor's PAP Released Device + Pressure Support A |
| Competitor's PAP Released Device + Pressure Support B | Active comparator | Device: Competitor's PAP Released Device + Pressure Support BCompetitor's PAP Released Device + Pressure Support B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 and over
- Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP.
- For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator)
Key exclusion criteria (6 listed)
- Contraindicated for PAP (CPAP or AutoCPAP) therapy
- Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
- Persons with obesity hypoventilation syndrome or congestive heart failure.
- Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device
- Persons with implanted electronic medical device (e.g cardiac pacemakers)
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 |
|---|---|---|
| FPH Device with SensAwake On + Pressure Support AFPH Device with SensAwake On + Pressure Support A | Device | FPH Device with SensAwake On + Pressure Support A |
| FPH Device with SensAwake Off + Pressure Support AFPH Device with SensAwake Off + Pressure Support A | Device | FPH Device with SensAwake Off + Pressure Support A |
| FPH Device with SensAwake On + Pressure Support BFPH Device with SensAwake On + Pressure Support B | Device | FPH Device with SensAwake On + Pressure Support B |
| FPH Device with SensAwake Off + Pressure Support BFPH Device with SensAwake Off + Pressure Support B | Device | FPH Device with SensAwake Off + Pressure Support B |
| Competitor's PAP Released Device + Pressure Support ACompetitor's PAP Released Device + Pressure Support A | Device | Competitor's PAP Released Device + Pressure Support A |
| Competitor's PAP Released Device + Pressure Support BCompetitor's PAP Released Device + Pressure Support B | Device | Competitor's PAP Released Device + Pressure Support B |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: 3 nights
Through the device and independent flow logger
Apnea Hypopnea Index (AHI)
Time frame: 1 night
Through the polysomnography
4 secondary outcomes
Therapy Comfort
Time frame: 3 nights
Compliance
Time frame: 3 nights
Device Triggering
Time frame: 3 nights
Device Triggering
Time frame: 1 night
Results and safety
The study was stopped early (reason given: project progression decision was able to be made with the data already gathered). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPH Device with SensAwake On + Pressure Support A, FPH Device with SensAwake Off + Pressure Support A and FPH Device with SensAwake On + Pressure Support B in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 2 sites in New Zealand.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. 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?
The study was stopped early (reason given: project progression decision was able to be made with the data already gathered). Results are not available in the source record.
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 (AHI) (time frame: 3 nights). The study lists 2 primary outcomes in all. 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 2 Aug 2018.