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NCT06535932 · ClinicalTrials.gov registry record · NA

Amara View Benchmark Study

A NA study, sponsored by Philips Clinical & Medical Affairs Global.

Completed
Registry status
NA
Development phase
35
Enrollment target

NCT06535932: Completed NA study, sponsored by Philips Clinical & Medical Affairs Global.

NCT06535932 is a NA study that has completed, run by Philips Clinical & Medical Affairs Global. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06535932, a NA study, has completed, sponsored by Philips Clinical & Medical Affairs Global.

COMPLETED
Registry status
NA
Development phase
35 participants
Enrollment target

Study 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.

Primary Outcome

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 individ

Interventions

  • DEVICE Amara View Minimal Contact Full Face Mask
  • DEVICE F40 Minimal Contact Full Face Mask

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2024-07-25
Est. Completion 2024-09-06
Phase NA

What the finished NCT06535932 record still lists

NCT06535932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Amara View Minimal Contact Full Face Mask is the first listed.

NCT06535932 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT06535932 about?

NCT06535932 is a clinical study titled "Amara View Benchmark Study". 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 AirFi...

What is the current status of trial NCT06535932?

This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2024-07-25. Estimated completion is 2024-09-06.

What interventions are being tested in trial NCT06535932?

The interventions under investigation include: Amara View Minimal Contact Full Face Mask (DEVICE), F40 Minimal Contact Full Face Mask (DEVICE).

Who is sponsoring clinical trial NCT06535932?

This trial is sponsored by Philips Clinical & Medical Affairs Global, which has 45 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT06535932's enrollment target sits among peer trials

35 1564th of 2000 higher than 431 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06535932, the US trial registry maintained by the National Library of Medicine. NCT06535932 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.