Obstructive Sleep ApneaNCT06036329
Whitsundays (Nasal) Mask Take Home Study (90 Days)
A study testing Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion and Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions in people with Obstructive Sleep Apnea, run by ResMed at 2 sites in United States.
Trial summary
The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea. 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?
- Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion and Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 May 2023to 6 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
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients who ≥ 18 years of age
- Patients being treated for OSA with a PAP device for ≥ 6 months
- Patients currently using a ResMed PAP device (S9, AirSense 10 \& AirSense 11) compatible with AirView (with cellular data connectivity and has been sending device data to the cloud)
- Patients currently using ResMed AirFit N30i or Philips DreamWear™ Nasal
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- Patients who are willing to try the prototype mask for up to 90 nights
- Patients who are willing to take photos of the prototype mask every 2 weeks for the duration of the study
- Patients who reside in the USA and intend to stay in the USA for the next 6 months
- Patients with access to the internet (such as a smartphone or laptop) to complete online surveys
Who cannot join
- Patients using Bilevel flow generators
- Patients who are or may be pregnant
- Patients with a preexisting 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.
- If you are pregnant or planning to become pregnant
- Patients 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: Evaluating the Usability and Performance of a PAP Mask System in the Home Environment
The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea. The main questions it aims to answer are:
- How the Whitsundays masks performs in the home environment
- What is the subject's first impression of the Whitsundays mask and what is their preference compared to their own mask
- What is the difference between the subject's objective therapy data when using the Whitsundays mask compared to their own mask
- Is there wear and tear of the Whitsundays mask and how frequently do the cushions need replacement Participants will be asked to use the Whitsundays mask for 90 days, answer questionnaires about the initial impression of the mask, the performance of the mask, and their preference compared to their own mask. Researchers will compare one group of subjects who will be provided with cushion replacements to another group who will only be provided with cushion replacements upon request to determine the need for cushion replacement, its frequency, and the reasons for cushion replacement during home usage.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion, Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
- 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.
Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushionDevice
Group A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested)
Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushionsDevice
Group B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
| Study group | Role | What they receive |
|---|---|---|
| Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion | Experimental | • Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested) Receives: Device: Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion |
| Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions | Experimental | • Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions Receives: Device: Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions |
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. visual appeal, ease of use, ease of cleaning, seal, comfort, overall performance 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: 90 days
Secondary outcomes (8)
11 point Likert Scale Questionnaire
- Subject's subjective impression and comments comparing the prototype mask (Whitsundays Nasal) to the subject's current mask with regards to ease of use, visual appearance, seal, comfort, facial markings, noise and overall performance. • 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: 90 days
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 Whitsundays mask. The AHI will be obtained from the ResMed AirView Compliance Reports downloaded from the subject's PAP device during the study visits.
Measured: 90 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 Whitsundays 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: 90 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 Whitsundays mask. The median air leak will be obtained from the ResMed AirView Compliance Reports downloaded during the study visits.
Measured: 90 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 Whitsundays 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: 90 days
Frequency of Cushion Replacement
- Subject's frequency of cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
Measured: 90 days
Reason for Cushion Replacement
- Subject's reason for cushion replacement will be recorded using the Mask Cushion Change Form to be provided to Group B participants on Day 14 and every 2 weeks for the duration of the study. The Mask Cushion Change form will be provided to Group A participants who request a cushion change.
Measured: 90 days
Deterioration of Mask
- Photos of the subject's prototype mask system taken at 2-week intervals to observe any visual deterioration such as cracking, crazing, tears, dirt or stain build up
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start31 May 2023
- Primary completion6 Nov 2023
- Study completion6 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Hevener, RPSGT, Principal investigator, Sleep DataMatthew Uhles, MS, Principal investigator, Clayton Sleep Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036329
- Sponsor's protocol ID
- SLP-23-02-01
- Other IDs
- D638-1118
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 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
- Evaluating the Usability and Performance of a PAP Mask System in the Home Environment
- ClinicalTrials.gov ID
- NCT06036329
- Acronym / sponsor ID
- SLP-23-02-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 6 Nov 2023 (actual)
- Study completion
- 6 Nov 2023 (actual)
- First posted
- 13 Sep 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 multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea. The main questions it aims to answer are:
- How the Whitsundays masks performs in the home environment
- What is the subject's first impression of the Whitsundays mask and what is their preference compared to their own mask
- What is the difference between the subject's objective therapy data when using the Whitsundays mask compared to their own mask
- Is there wear and tear of the Whitsundays mask and how frequently do the cushions need replacement Participants will be asked to use the Whitsundays mask for 90 days, answer questionnaires about the initial impression of the mask, the performance of the mask, and their preference compared to their own mask. Researchers will compare one group of subjects who will be provided with cushion replacements to another group who will only be provided with cushion replacements upon request to determine the need for cushion replacement, its frequency, and the reasons for cushion replacement during home usage.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion | Experimental | Device: Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion• Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested) |
| Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions | Experimental | Device: Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions• Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients who ≥ 18 years of age
- Patients being treated for OSA with a PAP device for ≥ 6 months
- Patients currently using a ResMed PAP device (S9, AirSense 10 \& AirSense 11) compatible with AirView (with cellular data connectivity and has been sending device data to the cloud)
Key exclusion criteria (5 listed)
- Patients using Bilevel flow generators
- Patients who are or may be pregnant
- Patients with a preexisting 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.
- If you are pregnant or planning to become pregnant
- Patients believed to be unsuitable for inclusion by the researcher
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 |
|---|---|---|
| Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushionGroup A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested) | Device | Group A provided with 1 Whitsundays Nasal mask without a spare mask cushion |
| Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushionsGroup B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions | Device | Group B provided with 1 Whitsundays Nasal mask with 2 spare mask cushions |
Primary outcome
11 point Likert Scale Questionnaire
Time frame: 90 days
• Subjective scores will be collected from subjects on each attribute being assessed (e.g. visual appeal, ease of use, ease of cleaning, seal, comfort, overall performance 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.
8 secondary outcomes
11 point Likert Scale Questionnaire
Time frame: 90 days
Apnea Hypopnea Index (AHI)
Time frame: 90 days
Compliance
Time frame: 90 days
Leak
Time frame: 90 days
Pressure Differences
Time frame: 90 days
Frequency of Cushion Replacement
Time frame: 90 days
Reason for Cushion Replacement
Time frame: 90 days
Deterioration of Mask
Time frame: 90 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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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.
William Hevener, RPSGT principal investigator
Sleep Data
Matthew Uhles, MS principal investigator
Clayton Sleep Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion and Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions 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 10 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 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: 90 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.