Sleep Disordered BreathingNCT02851628
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort
A study testing Alternative sizing model based trial mask and Prototype Full Face Mask in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 4 sites in New Zealand.
Trial summary
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. 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?
- Alternative sizing model based trial mask and Prototype Full Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesNew Zealand
- Study dates
- 11 Sep 2017to 20 Dec 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
- Adult (18+ years of age)
- Able to give consent
- Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
- Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
- Existing nasal or full face mask user.
Who cannot join
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness.
- Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of CO2 retention
- Pregnant or may think they are pregnant.
Trial locations and contacts
4 sites in 1 country.
New Zealand4 sites
Fisher & Paykel Healthcare
Auckland, 2013
Waikato Hospital (Waikato DHB)
Hamilton, Waikato Region, 3204
Hastings Memorial Hospital
Hastings, Hawkes Bay, 1420
Bowen Hospital
Wellington, 6035
About this study
Official title: The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.
Read the detailed description
The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher \& Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand.
The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.
- Being tested
- Alternative sizing model based trial mask, Prototype Full Face Mask
- 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.
Alternative sizing model based trial maskDevice
A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.
Prototype Full Face MaskDevice
A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.
| Study group | Role | What they receive |
|---|---|---|
| Alternative sizing model trial mask | Experimental | In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm. Receives: Device: Alternative sizing model based trial mask |
| Prototype Full Face Mask (PFFM) | Active comparator | In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm. Receives: Device: Prototype Full Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seal Comfort
Obtained from subjective questionnaire
Measured: Up to 3 weeks in-home
Subjective Seal Leak
Obtained from subjective questionnaire
Measured: Up to 3 weeks in-home
Objective Seal Leak
Measured by device data
Measured: Up to 3 weeks in-home
Secondary outcomes (2)
Objective correct mask selection
Measured by device leak data
Measured: Up to 3 weeks in-home
Subjective correct mask selection
Measured by subjective questionnaire
Measured: Up to 3 weeks in-home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study start11 Sep 2017
- Primary completion3 Nov 2017
- Study completion20 Dec 2017
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kayan Gonda, BSc, Principal investigator, Sponsor Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851628
- Sponsor's protocol ID
- CIA-194
- Status last verified
- Apr 2018
- First submitted
- 28 Jul 2016
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot investigation from which data will be used to inform product development on future projects and investigations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort
- ClinicalTrials.gov ID
- NCT02851628
- Acronym / sponsor ID
- CIA-194
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2017 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 1 Aug 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 investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.
Detailed description
The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher \& Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand.
The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative sizing model trial mask | Experimental | Device: Alternative sizing model based trial maskIn this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm. |
| Prototype Full Face Mask (PFFM) | Active comparator | Device: Prototype Full Face MaskIn this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18+ years of age)
- Able to give consent
- Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
- Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
- Existing nasal or full face mask user.
Key exclusion criteria (6 listed)
- Inability to give consent
- Patients who are in a coma or a decreased level of consciousness.
- Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of CO2 retention
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 |
|---|---|---|
| Alternative sizing model based trial maskA trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy. | Device | Alternative sizing model trial mask |
| Prototype Full Face MaskA prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy. | Device | Prototype Full Face Mask (PFFM) |
Primary outcome
Seal Comfort
Time frame: Up to 3 weeks in-home
Obtained from subjective questionnaire
Subjective Seal Leak
Time frame: Up to 3 weeks in-home
Obtained from subjective questionnaire
Objective Seal Leak
Time frame: Up to 3 weeks in-home
Measured by device data
2 secondary outcomes
Objective correct mask selection
Time frame: Up to 3 weeks in-home
Subjective correct mask selection
Time frame: Up to 3 weeks 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 18 Apr 2018.
- Individual participant dataSharing planned: No. This is a pilot investigation from which data will be used to inform product development on future projects and investigations.
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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.
Kayan Gonda, BSc principal investigator
Sponsor Employee
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative sizing model based trial mask and Prototype Full Face Mask in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 4 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 5 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 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Seal Comfort (time frame: Up to 3 weeks in-home). 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 18 Apr 2018.