Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535932
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Amara View Benchmarks Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Assessment of Patient Preference for the Amara View Full Face Mask Compared to the ResMed AirFit F40 -a Benchmark Protocol
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1At 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 participants 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 participants prescribed pressure mask cushionframe 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None