Sleep Apnea SyndromesNCT06535932
Amara View Benchmark Study
A study testing Amara View Minimal Contact Full Face Mask and F40 Minimal Contact Full Face Mask in people with Sleep Apnea Syndromes, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
This randomized crossover, benchmark clinical trial aims to compare the Philips Amara View and ResMed AirFit F40 minimal contact full face masks on patient preference of mask attributes and usage parameters. At the first study visit participants will be fitted with either the Amara View or the AirFit F40. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Amara View Minimal Contact Full Face Mask and F40 Minimal Contact Full Face Mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2024to 6 Sep 2024
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21-85 years (inclusive)
- Weight >66 pounds/30 kg
- Established on PAP for ≥90 days at the time of consent
- Currently prescribed and using fixed pressure, Auto CPAP, or Bi-Level therapy on a regular basis (average PAP usage of ≥4 hours/night, ≥ 4 days per week for ≥3 months)
- Currently using a Full-Face mask
- Able to read, write, speak and understand English
Show all 9Show fewer
- Willing and able to provide informed consent
- Willing and able to follow instructions and complete all activities required by the study
- Able to remove a sleep apnea mask without assistance
Who cannot join
- Currently using a Philips Respironics Amara View FFM or ResMed AirFit F40 FFM
- Allergy to silicone
- Allergy to latex
- Unique facial features (i.e., deformities of the face and/or head, piercings, etc.) that could interfere with the therapeutic use of this type of mask
- Employee or living with a family member who works for Philips or any company that designs, sells, or manufactures sleep-related products.
- Prescribed oxygen at night or continuously
Show all 53Show fewer
- Recent eye surgery or dry eyes
- Hiatal hernia
- Excessive reflux
- Impaired cough reflux
- Impaired cardiac sphincter function
- Using prescription drugs that induce vomiting
- Currently participating in another interventional research study or planned participation in another interventional clinical research study during the trial period
- Prescribed an ASV (adaptive servo-ventilation) device
- Prescribed mechanical ventilation
- Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks, or cribriform plate abnormalities
- Any unstable medical condition (e.g., uncontrolled cardiac, lung, or neurological disease) or limitation that would affect the participant's ability to complete trial activities
- Experiencing any acute illness (e.g., acute sinusitis, ear or eye infections, upper respiratory infections, pharyngitis, bronchitis, pleurisy, pneumonia, or facial dermatitis) that would impact their ability to use the mask and/or PAP therapy during the trial
- Surgical procedures involving the head, neck, face (eyes, ears, nose), or lungs in the previous 90 days or taking place any time during the trial period
- Pregnant
- Advised by a health care provider to avoid magnets
- Patient or patient's household member, caregiver or bed partner in close vicinity currently using medical implants or medical devices that would be affected by magnets, including but not limited to:
- Pacemakers
- Implantable cardioverter defibrillators (ICD)
- Neurostimulators
- Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
- Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
- Aneurysm clips
- Embolic coils
- Intracranial aneurysm intravascular flow disruption devices
- Metallic cranial plates, screws, burr hole covers, and bone substitute devices
- Metallic splinters in the eye
- Ocular implants (e.g., glaucoma implants, retinal implants)
- Certain contact lenses with metal
- Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
- Magnetic denture attachments
- Metallic gastrointestinal clips
- Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
- Implantable ports and pumps (e.g., insulin/infusion pumps)
- Hypoglossal nerve stimulators
- Devices labeled as MR (Magnetic Resonance) unsafe
- Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field
- PAP device is unknown, or they are using a recalled device that has not yet been remediated. Recalled devices include:
- DreamStation CPAP, Auto CPAP, or BiPAP
- DreamStation BiPAP, autoSV (ASV)
- DreamStation ST, AVAPS (Also known as DreamStation BiPAP AVAPS or DreamStation BiPAP S/T)
- DreamStation Go CPAP, APAP or Auto CPAP
- Dorma 400 or 500 CPAP or Auto CPAP
- System One ASV4
- System One (Q-Series) 50 series CPAP, Auto CPAP, or BiPAP
- System One (Q-Series) 60 series CPAP, Auto CPAP, or BiPAP
- C Series ASV, S/T, or AVAPS
- REMStar SE Auto CPAP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of Patient Preference for the Amara View Full Face Mask Compared to the ResMed AirFit F40 -a Benchmark Protocol
This randomized crossover, benchmark clinical trial aims to compare the Philips Amara View and ResMed AirFit F40 minimal contact full face masks on patient preference of mask attributes and usage parameters. At the first study visit participants will be fitted with either the Amara View or the AirFit F40. The order in which participants will use the masks will be randomized. After the fitting and completion of informed consent, eligibility, and baseline questionnaires, participants will take home the first mask and use it with their prescribed PAP device for 15-days. After the first 15-day time period participants will return for their second visit. At this visit participants will return the first mask to the study team and complete a survey on the mask attributes. They will then be fitted with the second study mask and will be given the mask to take home and use with their prescribed PAP device for 15-days. At the end of the second 15-day trial period, participants will return for the third study visit. At this visit they will return the second mask and complete a mask attributes survey on the second mask.
Read the detailed description
Participants will be recruited via a sleep clinic contracted to recruit participants within the United States. Study staff will be responsible for assessment of inclusion and exclusion criteria. Scheduling will be conducted by the site. Participants who are willing to enroll will be scheduled for an in-person visit to provide informed consent and complete study procedures. During the baseline visit, review the Informed Consent Form (ICF) with the participant explaining and answering any questions the participant may have about the study. If the participant is willing to take part in the study, the ICF will be signed and dated by the participant and the site study representative obtaining consent. Those who provide consent will then complete the Demographics Questionnaire, Baseline Mask Survey, and Eligibility Questionnaire to confirm entry criteria. Participants will be asked to bring their prescribed mask and PAP device to Visit 1.At the initial visit, participants will undergo a fitting of the mask they are randomized to start the study with; either the Amara View or the AirFit F40 mask. Participants will be fit with mask sizes recommended by the clinician. The clinician will use the provided sizing gauges for the Amara View and AirFit F40 masks respectively. Once a mask size is selected for the first study mask, the participant will undergo short trials using his or her own PAP machine at therapeutic pressure, and an assessment of mask fit will be performed. If the participant's PAP device is not available, they will be fitted with the mask and will undergo short trials using a PAP device provided by the site. Participants may be fitted with up to three mask sizes for the mask. A Mask Fitting Survey will be used to capture the participant's prescribed pressure, mask (cushion/frame) sizes and fitting observations for the first study mask.
After the mask fitting, participants will be given the first study mask to take home. They will be encouraged to use the mask for the full 15-days of the first trial period. After the first 15-day trial period with the first study mask, participants will return to the site for their second study visit. Participants will be instructed to bring their PAP device and the first study mask to the visit. Participants will complete a mask attributes survey on the first study mask and then they will be fitted with the second study mask. Fitting procedures will follow the same procedure as described above in the baseline visit. After the mask fitting, participants will be given the second study mask to take home. They will be encouraged to use the mask for the full 15 days of the second trial period. After the second 15-day trial period with the second study mask, participants will return to the site for the third and final study visit. During this visit, participants will complete a mask-attributes survey on the second study mask and return all study product.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Amara View Minimal Contact Full Face Mask, F40 Minimal Contact Full Face Mask
- Keywords
- Positive Airway Pressure Therapy, Minimal contact full face mask
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amara View Minimal Contact Full Face MaskDevice
The Amara View Full-Face Mask is a minimal contact full face mask manufactured by Philips Respironics (Murrysville, PA) that covers the mouth and seals under the nose compared to traditional full-face masks which seal over the nose. The Amara View mask is intended to reduce discomfort on the bridge of the nose. There is no forehead arm, offering patients an enhanced design to keep the field of vision clear.
F40 Minimal Contact Full Face MaskDevice
The AirFit F40 is a minimal contact FFM manufactured by ResMed (San Diego, CA) that rests softly and securely under the patients nose and is designed to let patients sleep in any position and move freely throughout the night. The mask consists of three cushion sizes and three headgear sizes. Headgear adjustments can be made with magnetic clips that easily snap on and off.
| Study group | Role | What they receive |
|---|---|---|
| Amara View Minimal Contact Full Face Mask | Active comparator | Participants will wear the Amara View mask for 15 days Receives: Device: Amara View Minimal Contact Full Face Mask |
| F40 Minimal Contact Full Face Mask | Active comparator | Participants will wear the F40 for 15 days Receives: Device: F40 Minimal Contact Full Face Mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Preference on Mask Attributes
Comparison in satisfaction ratings between the Amara View and the AirFit F40 on mask attributes including:
bed partner satisfaction, fit, comfort, ability to maintain a seal during use, stability of the mask, noise level, air venting, comfort of breathing, sleep quality, visual appeal, and overall satisfaction. The scale for each mask attribute ranges from 0 to 10, where 0 indicates the lowest satisfaction and 10 indicates highest satisfaction. Each mask attribute was rated and analyzed individually; the scores from the separate mask attributes were not totaled.
Measured: up to 35 days
Ease of Use
Ease of use and satisfaction ratings between the Amara View and the AirFit F40 on the following parameters: mask clips, mask overall, assembly, disassembly. The scale for each ease-of-use attribute ranges from 0 to 10, where 0 indicates the most difficult and 10 indicates the easiest. Each ease-of-use attribute was rated and analyzed individually; the scores from the separate attributes were not totaled.
Measured: up to 35 days
Difference in Net Promotor Score
Difference in the Net Promotor Score between the Amara View and AirFit F40. The Net Promotor score is based on a 0 to 10 scaled question "Would you recommend this (Amara View FFM or AirFit F40) mask to others?" where 0 indicates "unlikely to recommend" and 10 indicates "likely to recommend". The 0 to 10 scale is grouped into three categories: promoters (ratings 9-10), detractors (ratings 0-6), and neutral (7-8). Net Promoter Scores (NPS) were calculated by subtracting the percentage of detractors from the percentage of promoters: [% Promoters] - [% Detractors]. Ratings of 7-8 were considered neutral. The NPS scale ranges from -100 to 100. Scores less than 100 indicate that the percentage of detractors exceeds the percentage of promoters. Scores greater than 100 indicate the percentage of promoters exceeds the percentage of detractors. A NPS score of 0 indicates the percentages of promoters and detractors are equal.
Measured: Up to 35 days
Patient Preference
Percentage of patients who prefer the Amara View compared to the AirFit F40 for the following: seal, comfort, stability, noise level, headgear, mask cushion ease of use, less disruptive air venting, and overall preference.
Measured: Up to 35 days
Secondary outcomes (4)
Leak
Comparison of leak values between the Amara View and F40.
Measured: up to 35 days
Number of Sleep Apnea Events Per Hour Measured by the Residual Apnea Hypopnea Index (AHI)
Comparison of residual Apnea Hypopnea Index (AHI) between the Amara View and F40. Residual AHI refers to the remaining or persistent apnea-hypopnea index (AHI) after a patient has undergone treatment, typically continuous positive airway pressure (CPAP) therapy, for obstructive sleep apnea (OSA). It represents the number of apnea and hypopnea events per hour of sleep that still occur despite treatment.
Measured: up to 35 days
Air Pressure
Air pressure (cmH20) used during PAP therapy while using the Amara View and AirFit F40 masks.
Measured: 30 days
Adherence to PAP Therapy
Daily hours of use of PAP therapy while using the Amara View and AirFit F40 masks.
Measured: up to 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start25 Jul 2024
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
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 Sleep Apnea SyndromesStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Ojile, MD, Principal investigator, Clayton Sleep Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535932
- Sponsor's protocol ID
- SRC-300401-Amara ViewBenchmark
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2024
- Last updated
- 3 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Patient Preference for the Amara View Full Face Mask Compared to the ResMed AirFit F40 -a Benchmark Protocol
- ClinicalTrials.gov ID
- NCT06535932
- Acronym / sponsor ID
- SRC-300401-Amara ViewBenchmark
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Positive Airway Pressure Therapy, Minimal contact full face mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 2 Aug 2024 (actual)
- Results
- Posted 3 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized crossover, benchmark clinical trial aims to compare the Philips Amara View and ResMed AirFit F40 minimal contact full face masks on patient preference of mask attributes and usage parameters. At the first study visit participants will be fitted with either the Amara View or the AirFit F40. The order in which participants will use the masks will be randomized. After the fitting and completion of informed consent, eligibility, and baseline questionnaires, participants will take home the first mask and use it with their prescribed PAP device for 15-days. After the first 15-day time period participants will return for their second visit. At this visit participants will return the first mask to the study team and complete a survey on the mask attributes. They will then be fitted with the second study mask and will be given the mask to take home and use with their prescribed PAP device for 15-days. At the end of the second 15-day trial period, participants will return for the third study visit. At this visit they will return the second mask and complete a mask attributes survey on the second mask.
Detailed description
Participants will be recruited via a sleep clinic contracted to recruit participants within the United States. Study staff will be responsible for assessment of inclusion and exclusion criteria. Scheduling will be conducted by the site. Participants who are willing to enroll will be scheduled for an in-person visit to provide informed consent and complete study procedures. During the baseline visit, review the Informed Consent Form (ICF) with the participant explaining and answering any questions the participant may have about the study. If the participant is willing to take part in the study, the ICF will be signed and dated by the participant and the site study representative obtaining consent. Those who provide consent will then complete the Demographics Questionnaire, Baseline Mask Survey, and Eligibility Questionnaire to confirm entry criteria. Participants will be asked to bring their prescribed mask and PAP device to Visit 1.At the initial visit, participants will undergo a fitting of the mask they are randomized to start the study with; either the Amara View or the AirFit F40 mask. Participants will be fit with mask sizes recommended by the clinician. The clinician will use the provided sizing gauges for the Amara View and AirFit F40 masks respectively. Once a mask size is selected for the first study mask, the participant will undergo short trials using his or her own PAP machine at therapeutic pressure, and an assessment of mask fit will be performed. If the participant's PAP device is not available, they will be fitted with the mask and will undergo short trials using a PAP device provided by the site. Participants may be fitted with up to three mask sizes for the mask. A Mask Fitting Survey will be used to capture the participant's prescribed pressure, mask (cushion/frame) sizes and fitting observations for the first study mask.
After the mask fitting, participants will be given the first study mask to take home. They will be encouraged to use the mask for the full 15-days of the first trial period. After the first 15-day trial period with the first study mask, participants will return to the site for their second study visit. Participants will be instructed to bring their PAP device and the first study mask to the visit. Participants will complete a mask attributes survey on the first study mask and then they will be fitted with the second study mask. Fitting procedures will follow the same procedure as described above in the baseline visit. After the mask fitting, participants will be given the second study mask to take home. They will be encouraged to use the mask for the full 15 days of the second trial period. After the second 15-day trial period with the second study mask, participants will return to the site for the third and final study visit. During this visit, participants will complete a mask-attributes survey on the second study mask and return all study product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized crossover
| Arm | Type | Receives |
|---|---|---|
| Amara View Minimal Contact Full Face Mask | Active comparator | Device: Amara View Minimal Contact Full Face MaskParticipants will wear the Amara View mask for 15 days |
| F40 Minimal Contact Full Face Mask | Active comparator | Device: F40 Minimal Contact Full Face MaskParticipants will wear the F40 for 15 days |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 21-85 years (inclusive)
- Weight >66 pounds/30 kg
- Established on PAP for ≥90 days at the time of consent
- Currently prescribed and using fixed pressure, Auto CPAP, or Bi-Level therapy on a regular basis (average PAP usage of ≥4 hours/night, ≥ 4 days per week for ≥3 months)
- Currently using a Full-Face mask
Key exclusion criteria (53 listed)
- Currently using a Philips Respironics Amara View FFM or ResMed AirFit F40 FFM
- Allergy to silicone
- Allergy to latex
- Unique facial features (i.e., deformities of the face and/or head, piercings, etc.) that could interfere with the therapeutic use of this type of mask
- Employee or living with a family member who works for Philips or any company that designs, sells, or manufactures sleep-related products.
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 |
|---|---|---|
| Amara View Minimal Contact Full Face MaskThe Amara View Full-Face Mask is a minimal contact full face mask manufactured by Philips Respironics (Murrysville, PA) that covers the mouth and seals under the nose compared to traditional full-face masks which seal over the nose. The Amara View mask is intended to reduce discomfort on the bridge of the nose. There is no forehead arm, offering patients an enhanced design to keep the field of vision clear. | Device | Amara View Minimal Contact Full Face Mask |
| F40 Minimal Contact Full Face MaskThe AirFit F40 is a minimal contact FFM manufactured by ResMed (San Diego, CA) that rests softly and securely under the patients nose and is designed to let patients sleep in any position and move freely throughout the night. The mask consists of three cushion sizes and three headgear sizes. Headgear adjustments can be made with magnetic clips that easily snap on and off. | Device | F40 Minimal Contact Full Face Mask |
Primary outcome
Patient Preference on Mask Attributes
Time frame: up to 35 days
Comparison in satisfaction ratings between the Amara View and the AirFit F40 on mask attributes including: bed partner satisfaction, fit, comfort, ability to maintain a seal during use, stability of the mask, noise level, air venting, comfort of breathing, sleep quality, visual appeal, and overall satisfaction. The scale for each mask attribute ranges from 0 to 10, where 0 indicates the lowest satisfaction and 10 indicates highest satisfaction. Each mask attribute was rated and analyzed individually; the scores from the separate mask attributes were not totaled.
Ease of Use
Time frame: up to 35 days
Ease of use and satisfaction ratings between the Amara View and the AirFit F40 on the following parameters: mask clips, mask overall, assembly, disassembly. The scale for each ease-of-use attribute ranges from 0 to 10, where 0 indicates the most difficult and 10 indicates the easiest. Each ease-of-use attribute was rated and analyzed individually; the scores from the separate attributes were not totaled.
Difference in Net Promotor Score
Time frame: Up to 35 days
Difference in the Net Promotor Score between the Amara View and AirFit F40. The Net Promotor score is based on a 0 to 10 scaled question "Would you recommend this (Amara View FFM or AirFit F40) mask to others?" where 0 indicates "unlikely to recommend" and 10 indicates "likely to recommend". The 0 to 10 scale is grouped into three categories: promoters (ratings 9-10), detractors (ratings 0-6), and neutral (7-8). Net Promoter Scores (NPS) were calculated by subtracting the percentage of detractors from the percentage of promoters: [% Promoters] - [% Detractors]. Ratings of 7-8 were considered neutral. The NPS scale ranges from -100 to 100. Scores less than 100 indicate that the percentage of detractors exceeds the percentage of promoters. Scores greater than 100 indicate the percentage of promoters exceeds the percentage of detractors. A NPS score of 0 indicates the percentages of promoters and detractors are equal.
Patient Preference
Time frame: Up to 35 days
Percentage of patients who prefer the Amara View compared to the AirFit F40 for the following: seal, comfort, stability, noise level, headgear, mask cushion ease of use, less disruptive air venting, and overall preference.
4 secondary outcomes
Leak
Time frame: up to 35 days
Number of Sleep Apnea Events Per Hour Measured by the Residual Apnea Hypopnea Index (AHI)
Time frame: up to 35 days
Air Pressure
Time frame: 30 days
Adherence to PAP Therapy
Time frame: up to 35 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Joseph Ojile, MD principal investigator
Clayton Sleep Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amara View Minimal Contact Full Face Mask and F40 Minimal Contact Full Face Mask in people with Sleep Apnea Syndromes, run by Philips Clinical & Medical Affairs Global 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 9 inclusion and 53 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 3 Aug 2025. 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 3 Aug 2025). 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?
Patient Preference on Mask Attributes (time frame: up to 35 days). 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 3 Aug 2025.