Amara View Benchmark Study

NCT06535932 | Completed Results FDA Device

• 1 other identifier: SRC-300401-Amara ViewBenchmark
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes

Keywords

Positive Airway Pressure Therapy; Minimal contact full face mask

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Up to 35 days

Secondary Outcomes (4)

• Leak

  up to 35 days

• Number of Sleep Apnea Events Per Hour Measured by the Residual Apnea Hypopnea Index (AHI)

  up to 35 days

• Air Pressure

  30 days

• Adherence to PAP Therapy

  up to 35 days

Study Arms (2)

Amara View Minimal Contact Full Face Mask

ACTIVE COMPARATOR

Participants will wear the Amara View mask for 15 days

Device: Amara View Minimal Contact Full Face Mask

F40 Minimal Contact Full Face Mask

ACTIVE COMPARATOR

Participants will wear the F40 for 15 days

Device: F40 Minimal Contact Full Face Mask

Interventions

Amara View Minimal Contact Full Face Mask DEVICE

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.

Amara View Minimal Contact Full Face Mask

F40 Minimal Contact Full Face Mask DEVICE

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.

F40 Minimal Contact Full Face Mask

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Clayton Sleep Institute

St Louis, Missouri, 63123, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Sarah Bass
• Organization: Philips

sarah.bass@philips.com

240-278-0838

Study Officials

• Joseph Ojile, MD

  Clayton Sleep Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: N/A - No masking will be performed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized crossover

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: July 25, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: August 3, 2025
• Results First Posted: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)