Sleep Disordered BreathingNCT03725839
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
A study testing F&P Interface in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 3 sites in New Zealand.
Trial summary
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, Obstructive Sleep Apnea
- What is being tested?
- F&P Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesNew Zealand
- Study dates
- 5 Nov 2018to 30 Nov 2019
- 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
- Adult (18+ years of age)
- Able to give written consent
- AHI ≥ 5 on diagnostic night
- Either prescribed APAP, CPAP or Bi-level PAP for OSA
Who cannot join
- Inability to give written consent
- Anatomical or physiological conditions making PAP therapy inappropriate
- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or may think they are pregnant.
Trial locations and contacts
3 sites in 1 country.
New Zealand3 sites
Fisher & Paykel Healthcare
Auckland, 2013
Hawkes Bay Fallen Soldiers' Memorial Hospital
Hastings, Hawkes Bay, 4120
Well Sleep
Wellington, 6035
About this study
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.
Read the detailed description
A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.
- Being tested
- F&P Interface
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F&P InterfaceDevice
F\&P Interface to be used for OSA therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm | Experimental | F\&P Interface will be used by OSA participants in-home for 2 weeks. Receives: Device: F&P Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial Mask usability
Questionnaire on ease-of-use (very easy to very difficult) Subjective
Measured: 14 ± 4 days in home
Trial mask Performance
Questionnaire on performance (very good to very poor)- Subjective
Measured: 14 ± 4 days in home
Secondary outcomes (2)
Trial mask Reliability
Questionnaire on reliability - Subjective
Measured: 5 months and 2 weeks in home
Trial mask performance measured in L/min
Objective leak data from PAP device
Measured: 14 ± 4 days in home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start5 Nov 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhavi Ogra, Principal investigator, Clinical Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725839
- Sponsor's protocol ID
- CIA-249
- Status last verified
- Feb 2020
- First submitted
- 28 Oct 2018
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT03725839
- Acronym / sponsor ID
- CIA-249
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 31 Oct 2018 (actual)
- 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 investigation is designed to evaluate the performance as well as the patients overall acceptance of the interface.
Detailed description
A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm | Experimental | Device: F&P InterfaceF\&P Interface will be used by OSA participants in-home for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (18+ years of age)
- Able to give written consent
- AHI ≥ 5 on diagnostic night
- Either prescribed APAP, CPAP or Bi-level PAP for OSA
Key exclusion criteria (5 listed)
- Inability to give written consent
- Anatomical or physiological conditions making PAP therapy inappropriate
- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or may think they are pregnant.
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 |
|---|---|---|
| F&P InterfaceF\&P Interface to be used for OSA therapy | Device | Arm |
Primary outcome
Trial Mask usability
Time frame: 14 ± 4 days in home
Questionnaire on ease-of-use (very easy to very difficult) Subjective
Trial mask Performance
Time frame: 14 ± 4 days in home
Questionnaire on performance (very good to very poor)- Subjective
2 secondary outcomes
Trial mask Reliability
Time frame: 5 months and 2 weeks in home
Trial mask performance measured in L/min
Time frame: 14 ± 4 days in home
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 28 Feb 2020.
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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.
Bhavi Ogra principal investigator
Clinical Manager
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F&P Interface in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 3 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 4 inclusion and 5 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 28 Feb 2020. 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 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?
Trial Mask usability (time frame: 14 ± 4 days in home). 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 28 Feb 2020.