Trial Outcomes & Findings for Amara View Benchmark Study (NCT NCT06535932)
NCT ID: NCT06535932
Last Updated: 2025-08-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
up to 35 days
Results posted on
2025-08-03
Participant Flow
Participant milestones
| Measure |
Amara View First, Then ResMed AirFit F40
Participants wore the Amara View mask for the first15 days, then wore the ResMed Airfit F40 for the second 15 days.
|
ResMed AirFit F40 First, Then Philips Amara View
Participants wore the AirFit F40 for the first 15 days, then the Amara View for the second 15 days.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
19
|
|
Overall Study
COMPLETED
|
16
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amara View Benchmark Study
Baseline characteristics by cohort
| Measure |
All Participants
n=35 Participants
All participants were enrolled and randomized.
|
|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
20 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino/a
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino/a
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Known or not reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 35 daysPopulation: All 35 participants tried both masks in randomized order.
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.
Outcome measures
| Measure |
Amara View Minimal Contact Full Face Mask
n=35 Participants
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=35 Participants
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Patient Preference on Mask Attributes
Noise level
|
7.34 scores on a scale
Standard Deviation 3.16
|
8.43 scores on a scale
Standard Deviation 2.34
|
|
Patient Preference on Mask Attributes
Air venting
|
7.71 scores on a scale
Standard Deviation 2.64
|
9 scores on a scale
Standard Deviation 1.68
|
|
Patient Preference on Mask Attributes
Fit
|
7.66 scores on a scale
Standard Deviation 2.63
|
7.66 scores on a scale
Standard Deviation 2.53
|
|
Patient Preference on Mask Attributes
Comfort
|
7.2 scores on a scale
Standard Deviation 2.85
|
7.34 scores on a scale
Standard Deviation 3.02
|
|
Patient Preference on Mask Attributes
Ability to maintain a seal during use
|
6.66 scores on a scale
Standard Deviation 3.14
|
7.03 scores on a scale
Standard Deviation 3.26
|
|
Patient Preference on Mask Attributes
Stability of the mask
|
7.03 scores on a scale
Standard Deviation 3.25
|
6.51 scores on a scale
Standard Deviation 3.45
|
|
Patient Preference on Mask Attributes
Comfort of breathing
|
8.49 scores on a scale
Standard Deviation 2.34
|
8.43 scores on a scale
Standard Deviation 2.48
|
|
Patient Preference on Mask Attributes
Sleep quality
|
6.86 scores on a scale
Standard Deviation 3.42
|
7.11 scores on a scale
Standard Deviation 3
|
|
Patient Preference on Mask Attributes
Visual appeal
|
8.89 scores on a scale
Standard Deviation 1.37
|
8.91 scores on a scale
Standard Deviation 1.36
|
|
Patient Preference on Mask Attributes
Overall satisfaction
|
6.17 scores on a scale
Standard Deviation 3.34
|
6.69 scores on a scale
Standard Deviation 2.85
|
|
Patient Preference on Mask Attributes
Bed partner satisfaction
|
5.6 scores on a scale
Standard Deviation 3.87
|
7.07 scores on a scale
Standard Deviation 3.35
|
PRIMARY outcome
Timeframe: up to 35 daysPopulation: All 35 participants tried both masks in randomized order.
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.
Outcome measures
| Measure |
Amara View Minimal Contact Full Face Mask
n=35 Participants
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=35 Participants
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Ease of Use
Overall Ease of Use
|
7.09 scores on a scale
Standard Deviation 2.57
|
8.46 scores on a scale
Standard Deviation 2.15
|
|
Ease of Use
Mask clips
|
7.73 scores on a scale
Standard Deviation 2.63
|
8.79 scores on a scale
Standard Deviation 1.63
|
|
Ease of Use
Ease of attaching cushion
|
9.1 scores on a scale
Standard Deviation 1.41
|
8.8 scores on a scale
Standard Deviation 2.44
|
|
Ease of Use
Ease of removing cushion
|
8.87 scores on a scale
Standard Deviation 1.51
|
9.2 scores on a scale
Standard Deviation 1.42
|
PRIMARY outcome
Timeframe: Up to 35 daysDifference 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.
Outcome measures
| Measure |
Amara View Minimal Contact Full Face Mask
n=35 Participants
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=35 Participants
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Difference in Net Promotor Score
|
-28.6 scores on a scale
Interval -54.3 to -2.8
|
-11.4 scores on a scale
Interval -38.6 to 15.7
|
PRIMARY outcome
Timeframe: Up to 35 daysPopulation: The below percentages may not total 100 because some participants indicated no 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.
Outcome measures
| Measure |
Amara View Minimal Contact Full Face Mask
n=35 Participants
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=35 Participants
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Patient Preference
Stability
|
12 Participants
|
14 Participants
|
|
Patient Preference
Noise level
|
4 Participants
|
16 Participants
|
|
Patient Preference
Headgear
|
8 Participants
|
17 Participants
|
|
Patient Preference
Mask cushion ease of use
|
4 Participants
|
10 Participants
|
|
Patient Preference
Less disruptive air venting
|
2 Participants
|
14 Participants
|
|
Patient Preference
Seal
|
12 Participants
|
17 Participants
|
|
Patient Preference
Comfort
|
10 Participants
|
19 Participants
|
|
Patient Preference
Overall preference
|
9 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: up to 35 daysPopulation: Data only available from the four participants who used a Philips PAP device.
Comparison of leak values between the Amara View and F40.
Outcome measures
| Measure |
Amara View Minimal Contact Full Face Mask
n=4 Participants
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=4 Participants
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Leak
|
37.4 liters per minute
Standard Deviation 10.3
|
40.6 liters per minute
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: up to 35 daysPopulation: Data only available from the four participants who used a Philips PAP device.
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.
Outcome measures
| Measure |
Amara View Minimal Contact Full Face Mask
n=4 Participants
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=4 Participants
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Number of Sleep Apnea Events Per Hour Measured by the Residual Apnea Hypopnea Index (AHI)
|
3.27 events per hour
Standard Deviation 1.1
|
3.85 events per hour
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Data only available from the four participants who used a Philips PAP device.
Air pressure (cmH20) used during PAP therapy while using the Amara View and AirFit F40 masks.
Outcome measures
| Measure |
Amara View Minimal Contact Full Face Mask
n=4 Participants
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=4 Participants
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Air Pressure
|
10.6 cmH20
Standard Deviation 2.38
|
11.3 cmH20
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: up to 35 daysPopulation: Data only available from the four participants who used a Philips PAP device.
Daily hours of use of PAP therapy while using the Amara View and AirFit F40 masks.
Outcome measures
| Measure |
Amara View Minimal Contact Full Face Mask
n=4 Participants
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=4 Participants
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Adherence to PAP Therapy
|
5.58 hours per night
Standard Deviation 1.35
|
4.96 hours per night
Standard Deviation 1.33
|
Adverse Events
Amara View Minimal Contact Full Face Mask
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
F40 Minimal Contact Full Face Mask
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Amara View Minimal Contact Full Face Mask
n=35 participants at risk
Participants will wear the Amara View mask for 15 days
Amara View Minimal Contact Full Face Mask: 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 Mask
n=35 participants at risk
Participants will wear the F40 for 15 days
F40 Minimal Contact Full Face Mask: 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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
48.6%
17/35 • Over the one-month period that the participants were in the study (15 days per randomized mask).
|
51.4%
18/35 • Over the one-month period that the participants were in the study (15 days per randomized mask).
|
|
Respiratory, thoracic and mediastinal disorders
Breathing Discomfort
|
11.4%
4/35 • Over the one-month period that the participants were in the study (15 days per randomized mask).
|
14.3%
5/35 • Over the one-month period that the participants were in the study (15 days per randomized mask).
|
|
Gastrointestinal disorders
Aeorophagia
|
0.00%
0/35 • Over the one-month period that the participants were in the study (15 days per randomized mask).
|
2.9%
1/35 • Over the one-month period that the participants were in the study (15 days per randomized mask).
|
|
Musculoskeletal and connective tissue disorders
Knee Surgery
|
0.00%
0/35 • Over the one-month period that the participants were in the study (15 days per randomized mask).
|
2.9%
1/35 • Over the one-month period that the participants were in the study (15 days per randomized mask).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If PI wishes to publish study results, the Proposed Publication will be given to Philips for approval at least sixty (60) days prior to any disclosure or submission for presentation or publication. At the request of Philips, the PI agrees to (i) revise or delete any Philips' Confidential Information as requested by Philips and/or (ii) delay submission of the Proposed Publication for presentation or publication for an additional ninety (90) days to allow for filing of patient protection.
- Publication restrictions are in place
Restriction type: OTHER