Obstructive Sleep ApneaNCT03329352
Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
A study testing F&P Full-Face Mask in people with Obstructive Sleep Apnea, run by Fisher and Paykel Healthcare at 1 site in United States.
Trial summary
The 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 Full-Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2017to 31 Jul 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 diagnostic PSG night
- Aged 22 and over (FDA defined as adult)
- Either prescribed APAP, CPAP or Bi-Level PAP for OSA
- Existing full-face mask users
- Fluent in spoken and written English
Who cannot join
- Inability to give informed consent
- Patient intolerant to CPAP therapy
- 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
North Texas Lung and Sleep Clinic
Fort Worth, Texas, 76109
About this study
The 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
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.
The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask by a sleep technician for use in-home (Visit 2). The participant then will come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trial full-face mask they will be asked if they would like to continue using the trial mask for a further six months in home. There will be a follow up phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months.
The mask and CPAP (if used from the loan 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 Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to the study.
Data from initial 2 week trial is reported here.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- F&P Full-Face 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 Full-Face MaskDevice
The F\&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
| Study group | Role | What they receive |
|---|---|---|
| F&P Full-Face Mask | Experimental | Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3. Receives: Device: F&P Full-Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial Mask Comfort
Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).
Measured: 14 ± 5 days in-home
Participant Count of Acceptable Trial Mask Performance - Objective
Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective
Measured: 14 ± 5 days in-home
Trial Mask Seal Performance - Subjective
Determined from questionnaire - Subjective Uses a 5 point Likert Scale
Measured: 14 ± 5 days in-home
Trial Mask Ease of Cleaning
Determined from questionnaires - Subjective
A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard.
Measured: 14 ± 5 days in-home
Trial Mask Ease-of-use
Participants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort.
Measured: 14 ± 5 days in-home
Secondary outcomes (2)
Participant Count of Acceptable Mask Leak
Data recorded from PAP device reporting amount of air leaking from the mask during PAP therapy. If mask leak was over 60 L/min it was compared to the participants baseline leak values to assess if mask leak with the trial mask was acceptable or not.
Measured: 14 ± 5 days in-home
Participant Count of Seal Size Determination
Whether the sizing guide prediction tool used to size participants matched the trial administrators sizing prediction.
Measured: 1 day-time appointment (1 hour) Visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start3 Nov 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 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.
- 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
- Model description
- After a period of baseline, all enrolled participants will be put on the same trial mask.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Ostransky, MD, Principal investigator, Board Certified Sleep Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329352
- Sponsor's protocol ID
- CIA-227
- Status last verified
- Oct 2021
- First submitted
- 30 Oct 2017
- Last updated
- 10 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared with any other researchers or organizations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT03329352
- Acronym / sponsor ID
- CIA-227
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Posted 21 Sep 2021
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 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
The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.
The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask by a sleep technician for use in-home (Visit 2). The participant then will come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trial full-face mask they will be asked if they would like to continue using the trial mask for a further six months in home. There will be a follow up phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months.
The mask and CPAP (if used from the loan 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 Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to the study.
Data from initial 2 week trial is reported here.
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 Full-Face Mask | Experimental | Device: F&P Full-Face MaskParticipants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial full-face mask during this treatment arm. Participants on the extension will use for a further six months after Visit 3. |
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 diagnostic PSG night
- Aged 22 and over (FDA defined as adult)
- Either prescribed APAP, CPAP or Bi-Level PAP for OSA
- Existing full-face mask users
- Fluent in spoken and written English
Key exclusion criteria (5 listed)
- Inability to give informed consent
- Patient intolerant to CPAP therapy
- 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 Full-Face MaskThe F\&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3. | Device | F&P Full-Face Mask |
Primary outcome
Trial Mask Comfort
Time frame: 14 ± 5 days in-home
Determined from questionnaire - Subjective Uses a 5 point Likert Scale (Very Uncomfortable, Uncomfortable, Same as usual, Comfortable, Very Comfortable).
Participant Count of Acceptable Trial Mask Performance - Objective
Time frame: 14 ± 5 days in-home
Determined from AHI data, a measure of disease severity, recorded from the PAP device - Objective
Trial Mask Seal Performance - Subjective
Time frame: 14 ± 5 days in-home
Determined from questionnaire - Subjective Uses a 5 point Likert Scale
Trial Mask Ease of Cleaning
Time frame: 14 ± 5 days in-home
Determined from questionnaires - Subjective A single question asked participants to report their ability to clean the mask on a 5 point Likert Scale with scores ranging from very easy, easy, neutral, hard, and very hard.
Trial Mask Ease-of-use
Time frame: 14 ± 5 days in-home
Participants experience removing mask from face, determined from questionnaires and a sleep diary - Subjective Uses a 5 point Likert Scale. Also includes, discussion questions around comfort.
2 secondary outcomes
Participant Count of Acceptable Mask Leak
Time frame: 14 ± 5 days in-home
Participant Count of Seal Size Determination
Time frame: 1 day-time appointment (1 hour) Visit 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. IPD will not be shared with any other researchers or organizations.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
David Ostransky, MD principal investigator
Board Certified Sleep Specialist
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 Full-Face 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 10 Nov 2021. 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 Sep 2021). 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 10 Nov 2021.