Obstructive Sleep ApneaNCT03272763
A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
A study testing F&P Toffee mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- F&P Toffee mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 9 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI ≥ 5 from the diagnostic night
- Aged 22 and over (FDA defined as default)
- Either prescribed APAP, CPAP or Bi-level PAP for OSA
- Existing Full-Face mask user
- Fluent in spoken and written English
Who cannot join
- Inability to give informed consent
- Participant intolerant to PAP
- Anatomical or physiological conditions making PAP therapy inappropriate
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or think they may be pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
California Sleep Solutions
Roseville, California, 95661
About this study
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Read the detailed description
This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.
This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).
The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.
The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to the study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- F&P Toffee mask
- 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.
F&P Toffee maskDevice
Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
| Study group | Role | What they receive |
|---|---|---|
| F&P Toffee mask | Experimental | Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. Receives: Device: F&P Toffee mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial Mask Comfort
Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
Measured: 14 ± 5 days In-Home
Trial Mask Performance - Objective
Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
Measured: 14 ± 5 days In-Home
Trial Mask Performance - Subjective
Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective
Measured: 14 ± 5 days In-Home
Trial Mask Usability
Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective
Measured: During Visit Two - 20 minutes
Trial Mask Ease-of-Use
Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective
Measured: 14 ± 5 days In-Home
Secondary outcomes (3)
Mask Leak Data
Leak data recorded from PAP device - Objective
Measured: 14 ± 5 days In-Home
Seal Size Determination
Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.
Measured: 1 day-time appointment (1 hour) during Visit Two
Efficacy Data
AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective
Measured: 14 ± 5 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 posted6 Sep 2017
- Study start9 Oct 2017
- Primary completion29 Oct 2017
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- After a period of baseline, all enrolled participants will be put on the same trial mask.
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT03272763
- Sponsor's protocol ID
- CIA-225
- Status last verified
- May 2022
- First submitted
- 30 Aug 2017
- Last updated
- 21 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers or institutions. Identifiable participant data will not leave the site and all other data will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT03272763
- Acronym / sponsor ID
- CIA-225
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 29 Oct 2017 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Posted 21 Jun 2022
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 comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
Detailed description
This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.
This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).
The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.
The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- After a period of baseline, all enrolled participants will be put on the same trial mask.
| Arm | Type | Receives |
|---|---|---|
| F&P Toffee mask | Experimental | Device: F&P Toffee maskParticipants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AHI ≥ 5 from the diagnostic night
- Aged 22 and over (FDA defined as default)
- Either prescribed APAP, CPAP or Bi-level PAP for OSA
- Existing Full-Face mask user
- Fluent in spoken and written English
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Participant intolerant to PAP
- Anatomical or physiological conditions making PAP therapy inappropriate
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or think they may be 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 Toffee maskTrial Full-Face mask which comes with three seal sizes and two headgear sizes. | Device | F&P Toffee mask |
Primary outcome
Trial Mask Comfort
Time frame: 14 ± 5 days In-Home
Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
Trial Mask Performance - Objective
Time frame: 14 ± 5 days In-Home
Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
Trial Mask Performance - Subjective
Time frame: 14 ± 5 days In-Home
Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective
Trial Mask Usability
Time frame: During Visit Two - 20 minutes
Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective
Trial Mask Ease-of-Use
Time frame: 14 ± 5 days In-Home
Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective
3 secondary outcomes
Mask Leak Data
Time frame: 14 ± 5 days In-Home
Seal Size Determination
Time frame: 1 day-time appointment (1 hour) during Visit Two
Efficacy Data
Time frame: 14 ± 5 days In-Home
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers or institutions. Identifiable participant data will not leave the site and all other data will be de-identified.
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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.
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 Toffee mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
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 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 21 Jun 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 21 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Comfort (time frame: 14 ± 5 days In-Home). The study lists 5 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 21 Jun 2022; AzTrials last refreshed its copy on 30 Oct 2026.