Sleep Disordered BreathingNCT03092921
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
A study testing F&P Mask Seal and F&P Mask in people with Sleep Disordered Breathing and Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in New Zealand.
Trial summary
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/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?
- F&P Mask Seal and F&P Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNew Zealand
- Study dates
- 27 Mar 2017to 3 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
- Adult (18+ years of age)
- Able to give consent
- Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- Prescribed PAP for OSA
- Existing oro-nasal 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 automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency
- Current diagnosis of carbon dioxide (CO2) retention
- Pregnant or may think they are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.
Read the detailed description
A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.
An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.
- Being tested
- F&P Mask Seal, F&P 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.
F&P Mask SealDevice
Investigative Mask Seal to be used for OSA therapy
F&P MaskDevice
Investigative Mask to be used for OSA therapy
| Study group | Role | What they receive |
|---|---|---|
| F&P Mask Seal | Experimental | Participants to use trial seal in-home for 1 week Receives: Device: F&P Mask Seal |
| F&P Mask | Experimental | Participants to use trial mask in-home for 2 weeks Receives: Device: F&P Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of use
Subjective questionnaire
Measured: 1 week in home
Acceptability
Subjective questionnaire
Measured: 1 week in home
Ease of use
Subjective questionnaire
Measured: 2 weeks in home
Acceptability
Subjective questionnaire
Measured: 2 weeks in home
Secondary outcomes (1)
Objective leak data
Obtained from participants' device
Measured: 1 week in home
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start27 Mar 2017
- Primary completion3 Aug 2017
- Study completion3 Aug 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Gunson, Principal investigator, Employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092921
- Sponsor's protocol ID
- CIA-209
- Status last verified
- Aug 2017
- First submitted
- 22 Mar 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For product development purposes only. Data will be deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT03092921
- Acronym / sponsor ID
- CIA-209
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 3 Aug 2017 (actual)
- Study completion
- 3 Aug 2017 (actual)
- First posted
- 28 Mar 2017 (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 seal/mask.
Detailed description
A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.
An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F&P Mask Seal | Experimental | Device: F&P Mask SealParticipants to use trial seal in-home for 1 week |
| F&P Mask | Experimental | Device: F&P MaskParticipants to use trial mask 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 (5 listed)
- Adult (18+ years of age)
- Able to give consent
- Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- Prescribed PAP for OSA
- Existing oro-nasal 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 automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
- Commercial drivers who are investigated by New Zealand Transport Agency
- Current diagnosis of carbon dioxide (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 |
|---|---|---|
| F&P Mask SealInvestigative Mask Seal to be used for OSA therapy | Device | F&P Mask Seal |
| F&P MaskInvestigative Mask to be used for OSA therapy | Device | F&P Mask |
Primary outcome
Ease of use
Time frame: 1 week in home
Subjective questionnaire
Acceptability
Time frame: 1 week in home
Subjective questionnaire
Ease of use
Time frame: 2 weeks in home
Subjective questionnaire
Acceptability
Time frame: 2 weeks in home
Subjective questionnaire
1 secondary outcome
Objective leak data
Time frame: 1 week 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 8 Aug 2017.
- Individual participant dataSharing planned: No. For product development purposes only. Data will be deidentified.
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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.
Sarah Gunson principal investigator
Employee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing F&P Mask Seal and F&P Mask in people with Sleep Disordered Breathing and 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 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 8 Aug 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?
Ease of use (time frame: 1 week in home). 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 8 Aug 2017.