Obstructive Sleep ApneaNCT02948010
CPAP Device In-lab Assessment NZ
A study testing Auto CPAP + comfort feature A, Auto CPAP with comfort feature B and Auto CPAP with no comfort feature in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements 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?
- Auto CPAP + comfort feature A, Auto CPAP with comfort feature B and Auto CPAP with no comfort feature
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteNew Zealand
- Study dates
- Nov 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
- 18 years or older
- Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
- Fluent in spoken and written English.
Who cannot join
- Be contraindicated for PAP (fixed or auto CPAP) therapy.
- Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
- Have obesity hypoventilation syndrome or congestive heart failure.
- Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
- Have any implanted electronic medical devices (e.g. cardiac pacemakers).
- Be pregnant or think they might be pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
Read the detailed description
Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Auto CPAP + comfort feature A, Auto CPAP with comfort feature B, Auto CPAP with no comfort feature, Auto CPAP with comfort feature A+B, CPAP with comfort feature 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.
Auto CPAP + comfort feature ADevice
Auto CPAP + comfort feature A using Fisher \& Paykel Healthcare CPAP Device
Auto CPAP with comfort feature BDevice
Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device
Auto CPAP with no comfort featureDevice
Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device
Auto CPAP with comfort feature A+BDevice
Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device
CPAP with comfort feature ADevice
CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device
CPAP with comfort feature BDevice
CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device
CPAP with no comfort featureDevice
CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device
CPAP with comfort feature A + BDevice
CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device
CPAP at Sub therapeutic levelDevice
CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device
| Study group | Role | What they receive |
|---|---|---|
| Auto CPAP + comfort feature A | Active comparator | Auto CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device Receives: Device: Auto CPAP + comfort feature A |
| Auto CPAP with comfort feature B | Active comparator | Auto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device Receives: Device: Auto CPAP with comfort feature B |
| Auto CPAP with no comfort feature | Active comparator | Auto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device Receives: Device: Auto CPAP with no comfort feature |
| Auto CPAP with comfort feature A+B | Active comparator | Auto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device Receives: Device: Auto CPAP with comfort feature A+B |
| CPAP with comfort feature A | Active comparator | CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device Receives: Device: CPAP with comfort feature A |
| CPAP with comfort feature B | Active comparator | CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device Receives: Device: CPAP with comfort feature B |
| CPAP with no comfort feature | Active comparator | CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device Receives: Device: CPAP with no comfort feature |
| CPAP with comfort feature A + B | Active comparator | CPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device Receives: Device: CPAP with comfort feature A + B |
| CPAP at Sub therapeutic level | Active comparator | CPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device Receives: Device: CPAP at Sub therapeutic level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI) (i.e. number of events/hour).
Obtained from device and PSG data
Measured: 4 months
Log of safety-related events, measured as number of safety-related faults
Obtained from device
Measured: 4 months
Machine reported faults, measured as number of machine faults
Obtained from device
Measured: 4 months
Secondary outcomes (1)
Participant perception of the device, as determined by the questionnaire responses
Obtained through user questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startNov 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 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
- NCT02948010
- Sponsor's protocol ID
- CIA187
- Status last verified
- Jun 2017
- First submitted
- 26 Oct 2016
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 Device In-lab Assessment NZ
- ClinicalTrials.gov ID
- NCT02948010
- Acronym / sponsor ID
- CIA187
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 28 Oct 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 purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
Detailed description
Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Auto CPAP + comfort feature A | Active comparator | Device: Auto CPAP + comfort feature AAuto CPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device |
| Auto CPAP with comfort feature B | Active comparator | Device: Auto CPAP with comfort feature BAuto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device |
| Auto CPAP with no comfort feature | Active comparator | Device: Auto CPAP with no comfort featureAuto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device |
| Auto CPAP with comfort feature A+B | Active comparator | Device: Auto CPAP with comfort feature A+BAuto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device |
| CPAP with comfort feature A | Active comparator | Device: CPAP with comfort feature ACPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device |
| CPAP with comfort feature B | Active comparator | Device: CPAP with comfort feature BCPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device |
| CPAP with no comfort feature | Active comparator | Device: CPAP with no comfort featureCPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device |
| CPAP with comfort feature A + B | Active comparator | Device: CPAP with comfort feature A + BCPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device |
| CPAP at Sub therapeutic level | Active comparator | Device: CPAP at Sub therapeutic levelCPAP at Sub therapeutic level using Fisher \& 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 (3 listed)
- 18 years or older
- Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
- Fluent in spoken and written English.
Key exclusion criteria (6 listed)
- Be contraindicated for PAP (fixed or auto CPAP) therapy.
- Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
- Have obesity hypoventilation syndrome or congestive heart failure.
- Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
- Have any 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 |
|---|---|---|
| Auto CPAP + comfort feature AAuto CPAP + comfort feature A using Fisher \& Paykel Healthcare CPAP Device | Device | Auto CPAP + comfort feature A |
| Auto CPAP with comfort feature BAuto CPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device | Device | Auto CPAP with comfort feature B |
| Auto CPAP with no comfort featureAuto CPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device | Device | Auto CPAP with no comfort feature |
| Auto CPAP with comfort feature A+BAuto CPAP with comfort feature A+B using Fisher \& Paykel Healthcare CPAP Device | Device | Auto CPAP with comfort feature A+B |
| CPAP with comfort feature ACPAP with comfort feature A using Fisher \& Paykel Healthcare CPAP Device | Device | CPAP with comfort feature A |
| CPAP with comfort feature BCPAP with comfort feature B using Fisher \& Paykel Healthcare CPAP Device | Device | CPAP with comfort feature B |
| CPAP with no comfort featureCPAP with no comfort feature using Fisher \& Paykel Healthcare CPAP Device | Device | CPAP with no comfort feature |
| CPAP with comfort feature A + BCPAP with comfort feature A + B using Fisher \& Paykel Healthcare CPAP Device | Device | CPAP with comfort feature A + B |
| CPAP at Sub therapeutic levelCPAP at Sub therapeutic level using Fisher \& Paykel Healthcare CPAP Device | Device | CPAP at Sub therapeutic level |
Primary outcome
Apnea Hypopnea Index (AHI) (i.e. number of events/hour).
Time frame: 4 months
Obtained from device and PSG data
Log of safety-related events, measured as number of safety-related faults
Time frame: 4 months
Obtained from device
Machine reported faults, measured as number of machine faults
Time frame: 4 months
Obtained from device
1 secondary outcome
Participant perception of the device, as determined by the questionnaire responses
Time frame: 4 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.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auto CPAP + comfort feature A, Auto CPAP with comfort feature B and Auto CPAP with no comfort feature in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site 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: 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 1 site 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 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) (i.e. number of events/hour). (time frame: 4 months). The study lists 3 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.