Obstructive Sleep ApneaNCT06079866
Oran Park Mask External Clinical Study (3) Marketing Claims Study
A study testing Mask A (Oran Park Mask) then Mask B (Evora Mask) and Mask B (Evora Mask) then Mask A (Oran Park Mask) in people with Obstructive Sleep Apnea, run by ResMed at 2 sites in United States.
Trial summary
The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Mask A (Oran Park Mask) then Mask B (Evora Mask) and Mask B (Evora Mask) then Mask A (Oran Park Mask)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2023to 20 Nov 2023
- 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
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants who ≥ 18 years of age
- Participants being treated for OSA for ≥ 12 months
- Participants who have met CMS compliance for CPAP therapy over the last 3 months
- Participants who have been using a ResMed cloud connected AirSense10 or AirSense 11 device compatible with AirView, for more than 12 months
Show all 9Show fewer
- Participants currently using a suitable mask system*
- Participants who can trial the masks for up to 7 nights each
- Note*: Suitable mask system includes any tube down full face mask (e.g. AirFit F30, AirFit F20, AirTouch F20, AirFit F10, Quattro Air, Quattro Fx, Mirage Quattro, Simplus, Amara, Amara Gel, Comfort gel Full Face Mask, Evora Full)
Who cannot join
- Participants using Bi-level flow generators
- Participants who are or may be pregnant
- Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
- Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
- Participants who use a rental unit for AirSense 10 or AirSense 11 device
- Participants believed to be unsuitable for inclusion by the researcher
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sleep Data
San Diego, California, 92123
Clayton Sleep Institute
St Louis, Missouri, 63123
About this study
Official title: Assessment of the Seal, Comfort, Usability, and Performance of the Oran Park Mask System in the Home Environment
The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home environment. Comparisons will be made against Fisher \& Paykel's Evora Full mask system (referred to as Mask B in this study protocol, an FDA cleared benchmark mask) and the participant's own mask.
Patients diagnosed with Obstructive Sleep Apnea and are current CPAP users on a tube down full-face mask system will be recruited to the study to evaluate the Oran Park mask system and the Evora Full mask system for up to 7 nights each, in the home environment, whilst using their own CPAP device.
The overall purpose is to evaluate the performance of the prototype Oran Park mask system compared to an FDA cleared benchmark mask (Evora Full) in relation to seal, comfort, usability, ease of use, preference, AHI, and objective therapy data.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Mask A (Oran Park Mask) then Mask B (Evora Mask), Mask B (Evora Mask) then Mask A (Oran Park 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.
Mask A (Oran Park Mask) then Mask B (Evora Mask)Device
Mask A (Oran Park Mask) for 7 days followed by Mask B (Evora Mask) for 7 days
Mask B (Evora Mask) then Mask A (Oran Park Mask)Device
Mask B (Evora Mask) for 7 days followed by Mask A (Oran Park Mask) for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Mask A (Oran Park Mask) then Mask B (Evora Mask) | Other | Participants will be randomized as to the order they will trial Mask A and Mask B. This arm will first use the Oran Park mask for 7 days and then use the Evora Mask for 7 days. Receives: Device: Mask A (Oran Park Mask) then Mask B (Evora Mask) |
| Mask B (Evora Mask) then Mask A (Oran Park Mask) | Other | Participants will be randomized as to the order they will trial Mask A and Mask B. This arm will first use the Evora mask for 7 days and then use the Oran Park mask for 7 days. Receives: Device: Mask B (Evora Mask) then Mask A (Oran Park Mask) |
What is being measured
The primary outcome is the main question the study is designed to answer.
11 point Likert Scale Questionnaire
- Subjective scores will be collected from subjects on each attribute being assessed (e.g. seal, comfort, ease of use etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
Measured: 7 days
Secondary outcomes (4)
Apnea Hypopnea Index (AHI)
- The AHI recorded by the subject's PAP device while using their own mask will be compared to the AHI recorded by the subject's PAP device while using the Oran Park mask and the Evora Mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Measured: 7 days
Leak
The median air leak (L/minute) recorded by the subject's PAP device while using their own mask will be compared to the median air leak (L/minute) recorded by the subject's PAP device while using the Oran Park mask and the Evora mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits.
Measured: 7 days
Pressure Differences
The median air pressure (cmH2O) used during PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the median air pressure (cmH2O) recorded by the subject's PAP device while using the Oran Park mask and the Evora mask. The median air pressure levels will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Measured: 7 days
Compliance
The subject's average daily hours of use of PAP therapy recorded by the subject's PAP device while using their own mask will be compared to the average daily hours of use recorded by the subject's PAP device while using the Oran Park mask and the Evora mask. The average daily hours of use will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start4 Oct 2023
- Primary completion20 Nov 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe 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
- Model description
- Both masks (Oran Park Mask and Evora Mask (Mask A and Mask B)) will be worn for a period of 7 nights sequentially. Participants will complete a series of questionnaires upon completion.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Uhles, Principal investigator, Clayton Sleep InstituteBetsy Dauphin, Principal investigator, Sleep Data
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079866
- Sponsor's protocol ID
- SLP-23-04-01
- Other IDs
- D646-159
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Seal, Comfort, Usability, and Performance of the Oran Park Mask System in the Home Environment
- ClinicalTrials.gov ID
- NCT06079866
- Acronym / sponsor ID
- SLP-23-04-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 12 Oct 2023 (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.
The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home environment. Comparisons will be made against Fisher \& Paykel's Evora Full mask system (referred to as Mask B in this study protocol, an FDA cleared benchmark mask) and the participant's own mask.
Patients diagnosed with Obstructive Sleep Apnea and are current CPAP users on a tube down full-face mask system will be recruited to the study to evaluate the Oran Park mask system and the Evora Full mask system for up to 7 nights each, in the home environment, whilst using their own CPAP device.
The overall purpose is to evaluate the performance of the prototype Oran Park mask system compared to an FDA cleared benchmark mask (Evora Full) in relation to seal, comfort, usability, ease of use, preference, AHI, and objective therapy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both masks (Oran Park Mask and Evora Mask (Mask A and Mask B)) will be worn for a period of 7 nights sequentially. Participants will complete a series of questionnaires upon completion.
| Arm | Type | Receives |
|---|---|---|
| Mask A (Oran Park Mask) then Mask B (Evora Mask) | Other | Device: Mask A (Oran Park Mask) then Mask B (Evora Mask)Participants will be randomized as to the order they will trial Mask A and Mask B. This arm will first use the Oran Park mask for 7 days and then use the Evora Mask for 7 days. |
| Mask B (Evora Mask) then Mask A (Oran Park Mask) | Other | Device: Mask B (Evora Mask) then Mask A (Oran Park Mask)Participants will be randomized as to the order they will trial Mask A and Mask B. This arm will first use the Evora mask for 7 days and then use the Oran Park mask for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants who ≥ 18 years of age
- Participants being treated for OSA for ≥ 12 months
- Participants who have met CMS compliance for CPAP therapy over the last 3 months
Key exclusion criteria (6 listed)
- Participants using Bi-level flow generators
- Participants who are or may be pregnant
- Participants with a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury.
- Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
- Participants who use a rental unit for AirSense 10 or AirSense 11 device
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 |
|---|---|---|
| Mask A (Oran Park Mask) then Mask B (Evora Mask)Mask A (Oran Park Mask) for 7 days followed by Mask B (Evora Mask) for 7 days | Device | Mask A (Oran Park Mask) then Mask B (Evora Mask) |
| Mask B (Evora Mask) then Mask A (Oran Park Mask)Mask B (Evora Mask) for 7 days followed by Mask A (Oran Park Mask) for 7 days. | Device | Mask B (Evora Mask) then Mask A (Oran Park Mask) |
Primary outcome
11 point Likert Scale Questionnaire
Time frame: 7 days
• Subjective scores will be collected from subjects on each attribute being assessed (e.g. seal, comfort, ease of use etc.). Scores will be collected using an 11-point Likert Scale Questionnaire. Minimum value will be zero. Maximum value will be 10. A higher score indicates better outcomes. A score of 10 is considered very favorable, and a score of 0 is very unfavorable.
4 secondary outcomes
Apnea Hypopnea Index (AHI)
Time frame: 7 days
Leak
Time frame: 7 days
Pressure Differences
Time frame: 7 days
Compliance
Time frame: 7 days
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 29 Feb 2024.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Matthew Uhles principal investigator
Clayton Sleep Institute
Betsy Dauphin principal investigator
Sleep Data
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask A (Oran Park Mask) then Mask B (Evora Mask) and Mask B (Evora Mask) then Mask A (Oran Park Mask) in people with Obstructive Sleep Apnea, run by ResMed at 2 sites 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 9 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
11 point Likert Scale Questionnaire (time frame: 7 days). 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 29 Feb 2024.