Trial Outcomes & Findings for The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (NCT NCT03142438)
NCT ID: NCT03142438
Last Updated: 2021-07-14
Results Overview
Usability reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
14 ± 4 days in-Home
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
F&P Seal Improvement Project
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
F\&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
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|---|---|
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Overall Study
STARTED
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57
|
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Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
F&P Seal Improvement Project
n=57 Participants
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
F\&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
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|---|---|
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Age, Customized
22 or older
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57 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
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19 Participants
n=93 Participants
|
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Sex: Female, Male
Male
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38 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
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52 Participants
n=93 Participants
|
|
Region of Enrollment
New Zealand
|
5 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 14 ± 4 days in-HomeUsability reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Seal Improvement Project
n=57 Participants
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
F\&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
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|---|---|
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Number of Participants Subjective Usability Reporting
Easier
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14 Participants
|
|
Number of Participants Subjective Usability Reporting
The same
|
41 Participants
|
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Number of Participants Subjective Usability Reporting
More difficult
|
2 Participants
|
PRIMARY outcome
Timeframe: 14 ± 4 days in-HomeComfort reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea compared to usual
Outcome measures
| Measure |
F&P Seal Improvement Project
n=57 Participants
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
F\&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
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|---|---|
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Number or Participants Comparative Subjective Reported Comfort
More comfortable
|
27 Participants
|
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Number or Participants Comparative Subjective Reported Comfort
The same
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24 Participants
|
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Number or Participants Comparative Subjective Reported Comfort
Less comfortable
|
6 Participants
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SECONDARY outcome
Timeframe: 14 ± 4 days in-HomeObjective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Seal Improvement Project
n=57 Participants
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
F\&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
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|---|---|
|
Objective Performance Reporting
Lower AHI
|
17 Participants
|
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Objective Performance Reporting
No change in AHI
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3 Participants
|
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Objective Performance Reporting
Higher AHI
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8 Participants
|
|
Objective Performance Reporting
Not collected
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29 Participants
|
SECONDARY outcome
Timeframe: 14 ± 4 days in-HomeAcceptability reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Seal Improvement Project
n=57 Participants
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
F\&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
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|---|---|
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Number of Participants Reported Mask Acceptability
Happy to use improved
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27 Participants
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Number of Participants Reported Mask Acceptability
Not happy to use improved
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18 Participants
|
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Number of Participants Reported Mask Acceptability
Happy to use either
|
12 Participants
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SECONDARY outcome
Timeframe: 14 ± 4 days in-HomeComfort reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Seal Improvement Project
n=57 Participants
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
F\&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
|
|---|---|
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Number of Participants Subjective Comfort Reporting
Very comfortable
|
35 Participants
|
|
Number of Participants Subjective Comfort Reporting
Comfortable
|
16 Participants
|
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Number of Participants Subjective Comfort Reporting
Neither comfortable or uncomfortable
|
4 Participants
|
|
Number of Participants Subjective Comfort Reporting
Uncomfortable
|
2 Participants
|
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Number of Participants Subjective Comfort Reporting
Very uncomfortable
|
0 Participants
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SECONDARY outcome
Timeframe: 14 ± 4 days in-HomeSeal performance reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Seal Improvement Project
n=57 Participants
participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
F\&P Seal Improvement Project: Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
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|---|---|
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Number or Participants Subjective Reporting of Seal Performance
Very good
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28 Participants
|
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Number or Participants Subjective Reporting of Seal Performance
Good
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22 Participants
|
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Number or Participants Subjective Reporting of Seal Performance
Neither good nor poor
|
6 Participants
|
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Number or Participants Subjective Reporting of Seal Performance
Poor
|
1 Participants
|
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Number or Participants Subjective Reporting of Seal Performance
Very poor
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0 Participants
|
Adverse Events
F&P Seal Improvement Project
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place