Amara View Benchmark Study

Completed · Not applicable

Conditions studied: Sleep Apnea Syndromes

In brief

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.

Key facts

Study ID

NCT06535932

Run by

Philips Clinical & Medical Affairs Global

People needed

35

Starts

2024-07-25

Expected to finish

2024-09-06

Last updated by the study team

2025-08-03

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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