Sleep Apnea Syndromes
Conditions
Keywords
Positive Airway Pressure Therapy, Minimal contact full face mask
Brief 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. 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.
Interventions
DEVICEAmara 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.
DEVICEF40 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.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
N/A - No masking will be performed.
Intervention model description
Randomized crossover
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference | 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. |
| Patient Preference on Mask Attributes | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Leak | up to 35 days | Comparison of leak values between the Amara View and F40. |
| Number of Sleep Apnea Events Per Hour Measured by the Residual Apnea Hypopnea Index (AHI) | up to 35 days | 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. |
| Air Pressure | 30 days | Air pressure (cmH20) used during PAP therapy while using the Amara View and AirFit F40 masks. |
| Adherence to PAP Therapy | up to 35 days | Daily hours of use of PAP therapy while using the Amara View and AirFit F40 masks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants were enrolled and randomized. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 9.3 |
| Race/Ethnicity, Customized Hispanic or Latino/a | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino/a | 33 Participants |
| Race/Ethnicity, Customized Not Known or not reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment United States | 35 participants |
| Sex/Gender, Customized Female | 15 Participants |
| Sex/Gender, Customized Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 21 / 35 | 25 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
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.
Time frame: Up to 35 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amara View Minimal Contact Full Face Mask | Difference in Net Promotor Score | -28.6 scores on a scale |
| F40 Minimal Contact Full Face Mask | Difference in Net Promotor Score | -11.4 scores on a scale |
Primary
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.
Time frame: up to 35 days
Population: All 35 participants tried both masks in randomized order.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amara View Minimal Contact Full Face Mask | Ease of Use | Overall Ease of Use | 7.09 scores on a scale | Standard Deviation 2.57 |
| Amara View Minimal Contact Full Face Mask | Ease of Use | Mask clips | 7.73 scores on a scale | Standard Deviation 2.63 |
| Amara View Minimal Contact Full Face Mask | Ease of Use | Ease of attaching cushion | 9.1 scores on a scale | Standard Deviation 1.41 |
| Amara View Minimal Contact Full Face Mask | Ease of Use | Ease of removing cushion | 8.87 scores on a scale | Standard Deviation 1.51 |
| F40 Minimal Contact Full Face Mask | Ease of Use | Ease of removing cushion | 9.2 scores on a scale | Standard Deviation 1.42 |
| F40 Minimal Contact Full Face Mask | Ease of Use | Overall Ease of Use | 8.46 scores on a scale | Standard Deviation 2.15 |
| F40 Minimal Contact Full Face Mask | Ease of Use | Ease of attaching cushion | 8.8 scores on a scale | Standard Deviation 2.44 |
| F40 Minimal Contact Full Face Mask | Ease of Use | Mask clips | 8.79 scores on a scale | Standard Deviation 1.63 |
Primary
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.
Time frame: Up to 35 days
Population: The below percentages may not total 100 because some participants indicated no preference.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Amara View Minimal Contact Full Face Mask | Patient Preference | Headgear | 8 Participants |
| Amara View Minimal Contact Full Face Mask | Patient Preference | Stability | 12 Participants |
| Amara View Minimal Contact Full Face Mask | Patient Preference | Mask cushion ease of use | 4 Participants |
| Amara View Minimal Contact Full Face Mask | Patient Preference | Comfort | 10 Participants |
| Amara View Minimal Contact Full Face Mask | Patient Preference | Less disruptive air venting | 2 Participants |
| Amara View Minimal Contact Full Face Mask | Patient Preference | Noise level | 4 Participants |
| Amara View Minimal Contact Full Face Mask | Patient Preference | Overall preference | 9 Participants |
| Amara View Minimal Contact Full Face Mask | Patient Preference | Seal | 12 Participants |
| F40 Minimal Contact Full Face Mask | Patient Preference | Overall preference | 20 Participants |
| F40 Minimal Contact Full Face Mask | Patient Preference | Comfort | 19 Participants |
| F40 Minimal Contact Full Face Mask | Patient Preference | Stability | 14 Participants |
| F40 Minimal Contact Full Face Mask | Patient Preference | Noise level | 16 Participants |
| F40 Minimal Contact Full Face Mask | Patient Preference | Headgear | 17 Participants |
| F40 Minimal Contact Full Face Mask | Patient Preference | Mask cushion ease of use | 10 Participants |
| F40 Minimal Contact Full Face Mask | Patient Preference | Less disruptive air venting | 14 Participants |
| F40 Minimal Contact Full Face Mask | Patient Preference | Seal | 17 Participants |
Primary
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.
Time frame: up to 35 days
Population: All 35 participants tried both masks in randomized order.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Ability to maintain a seal during use | 6.66 scores on a scale | Standard Deviation 3.14 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Air venting | 7.71 scores on a scale | Standard Deviation 2.64 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Comfort | 7.2 scores on a scale | Standard Deviation 2.85 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Comfort of breathing | 8.49 scores on a scale | Standard Deviation 2.34 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Stability of the mask | 7.03 scores on a scale | Standard Deviation 3.25 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Sleep quality | 6.86 scores on a scale | Standard Deviation 3.42 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Fit | 7.66 scores on a scale | Standard Deviation 2.63 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Visual appeal | 8.89 scores on a scale | Standard Deviation 1.37 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Noise level | 7.34 scores on a scale | Standard Deviation 3.16 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Overall satisfaction | 6.17 scores on a scale | Standard Deviation 3.34 |
| Amara View Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Bed partner satisfaction | 5.6 scores on a scale | Standard Deviation 3.87 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Overall satisfaction | 6.69 scores on a scale | Standard Deviation 2.85 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Bed partner satisfaction | 7.07 scores on a scale | Standard Deviation 3.35 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Fit | 7.66 scores on a scale | Standard Deviation 2.53 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Comfort | 7.34 scores on a scale | Standard Deviation 3.02 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Ability to maintain a seal during use | 7.03 scores on a scale | Standard Deviation 3.26 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Stability of the mask | 6.51 scores on a scale | Standard Deviation 3.45 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Noise level | 8.43 scores on a scale | Standard Deviation 2.34 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Air venting | 9 scores on a scale | Standard Deviation 1.68 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Comfort of breathing | 8.43 scores on a scale | Standard Deviation 2.48 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Sleep quality | 7.11 scores on a scale | Standard Deviation 3 |
| F40 Minimal Contact Full Face Mask | Patient Preference on Mask Attributes | Visual appeal | 8.91 scores on a scale | Standard Deviation 1.36 |
Secondary
Adherence to PAP Therapy
Daily hours of use of PAP therapy while using the Amara View and AirFit F40 masks.
Time frame: up to 35 days
Population: Data only available from the four participants who used a Philips PAP device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amara View Minimal Contact Full Face Mask | Adherence to PAP Therapy | 5.58 hours per night | Standard Deviation 1.35 |
| F40 Minimal Contact Full Face Mask | Adherence to PAP Therapy | 4.96 hours per night | Standard Deviation 1.33 |
Secondary
Air Pressure
Air pressure (cmH20) used during PAP therapy while using the Amara View and AirFit F40 masks.
Time frame: 30 days
Population: Data only available from the four participants who used a Philips PAP device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amara View Minimal Contact Full Face Mask | Air Pressure | 10.6 cmH20 | Standard Deviation 2.38 |
| F40 Minimal Contact Full Face Mask | Air Pressure | 11.3 cmH20 | Standard Deviation 2.71 |
Secondary
Leak
Comparison of leak values between the Amara View and F40.
Time frame: up to 35 days
Population: Data only available from the four participants who used a Philips PAP device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amara View Minimal Contact Full Face Mask | Leak | 37.4 liters per minute | Standard Deviation 10.3 |
| F40 Minimal Contact Full Face Mask | Leak | 40.6 liters per minute | Standard Deviation 15.3 |
Secondary
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.
Time frame: up to 35 days
Population: Data only available from the four participants who used a Philips PAP device.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amara View Minimal Contact Full Face Mask | Number of Sleep Apnea Events Per Hour Measured by the Residual Apnea Hypopnea Index (AHI) | 3.27 events per hour | Standard Deviation 1.1 |
| F40 Minimal Contact Full Face Mask | Number of Sleep Apnea Events Per Hour Measured by the Residual Apnea Hypopnea Index (AHI) | 3.85 events per hour | Standard Deviation 0.98 |