N/A
Completed N=35
Amara View Benchmark Study
Sleep Apnea Syndromes
Source: ClinicalTrials.gov NCT06535932 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Patient Preference on Mask Attributes — 5.6; 7.07; 7.66; 7.66 scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Preference on Mask Attributes |
5.6; 7.07; 7.66; 7.66; 7.2; 7.34 | — |
| PRIMARY Ease of Use |
7.09; 8.46; 7.73; 8.79; 9.1; 8.8 | — |
| PRIMARY Difference in Net Promotor Score |
-28.6; -11.4 | — |
| PRIMARY Patient Preference |
12; 17; 10; 19; 12; 14 | — |
| SECONDARY Leak |
37.4; 40.6 | — |
| SECONDARY Number of Sleep Apnea Events Per Hour Measured by the Residual Apnea Hypopnea Index (AHI) |
3.27; 3.85 | — |
| SECONDARY Air Pressure |
10.6; 11.3 | — |
| SECONDARY Adherence to PAP Therapy |
5.58; 4.96 | — |
Eligibility Criteria
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)
- Dre
Data sourced from ClinicalTrials.gov (NCT06535932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.