Obstructive Sleep ApneaNCT02809794
CPAP In-home Assessment Australia
A study testing Fisher & Paykel Healthcare CPAP Device in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 3 sites in Australia.
Trial summary
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months. 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?
- Fisher & Paykel Healthcare CPAP Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesAustralia
- Study dates
- Jul 2016to Mar 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) therapy.
Who cannot join
- Persons contraindicated for Continuous Positive Airway Pressure (CPAP) 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 CPAP device.
- Persons with implanted electronic medical devices (e.g. cardiac pacemakers).
- Persons who are pregnant or think they might be pregnant.
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- Persons whose primary language is other than English.
- Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
- Persons highly dependent on medical care.
- People with cognitive impairment, an intellectual disability or a mental illness
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Sleep Matters
Bulleen, Victoria, 3105
Sleep & Snore Solutions
Bunbury, Western Australia, 6230
St John of God Midland Public Hospital
Midland, Western Australia, 6056
About this study
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
Read the detailed description
Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Fisher & Paykel Healthcare CPAP Device
- 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.
Fisher & Paykel Healthcare CPAP DeviceDevice
Fisher \& Paykel Healthcare CPAP Device
| Study group | Role | What they receive |
|---|---|---|
| Investigational CPAP device | Experimental | Fisher \& Paykel Healthcare CPAP Device Receives: Device: Fisher & Paykel Healthcare CPAP Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI), measured as number of events/hour
Obtained from the device
Measured: 6 months
Log of safety-related events, measured as number of safety-related faults
Obtained from the device
Measured: 6 months
Machine reported faults, measured as number of machine faults
Obtained from the device
Measured: 6 months
Participant reported faults, measured as number of participant complaints
Obtained from the follow up visits
Measured: 6 months
Secondary outcomes (1)
Perception of the device, measured through questionnaire
Impression of the device during the follow up visits
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017
- Study completionMar 2017
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT02809794
- Sponsor's protocol ID
- CIA175
- Status last verified
- Jun 2017
- First submitted
- 19 Jun 2016
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPAP In-home Assessment Australia
- ClinicalTrials.gov ID
- NCT02809794
- Acronym / sponsor ID
- CIA175
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 22 Jun 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.
The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.
Detailed description
Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational CPAP device | Experimental | Device: Fisher & Paykel Healthcare CPAP DeviceFisher \& Paykel Healthcare CPAP Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18 and over.
- Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.
Key exclusion criteria (10 listed)
- Persons contraindicated for Continuous Positive Airway Pressure (CPAP) 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 CPAP device.
- Persons with implanted electronic medical devices (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 |
|---|---|---|
| Fisher & Paykel Healthcare CPAP DeviceFisher \& Paykel Healthcare CPAP Device | Device | Investigational CPAP device |
Primary outcome
Apnea Hypopnea Index (AHI), measured as number of events/hour
Time frame: 6 months
Obtained from the device
Log of safety-related events, measured as number of safety-related faults
Time frame: 6 months
Obtained from the device
Machine reported faults, measured as number of machine faults
Time frame: 6 months
Obtained from the device
Participant reported faults, measured as number of participant complaints
Time frame: 6 months
Obtained from the follow up visits
1 secondary outcome
Perception of the device, measured through questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
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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 Fisher & Paykel Healthcare CPAP Device in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 3 sites in Australia.
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 2 inclusion and 10 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 27 Jun 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 Australia. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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), measured as number of events/hour (time frame: 6 months). The study lists 4 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 27 Jun 2017.