Trial Outcomes & Findings for A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea (NCT NCT03124069)
NCT ID: NCT03124069
Last Updated: 2021-07-14
Results Overview
Comfort reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
14 ± 5 days In-Home
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
F&P Nasal Mask
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Development Study to Evaluate a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
F&P Nasal
n=37 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days In-HomeComfort reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Nasal
n=37 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
.
|
|---|---|
|
Number of Participants Reporting Comfort Compared to Their Usual Mask.
Much better
|
17 Participants
|
|
Number of Participants Reporting Comfort Compared to Their Usual Mask.
Better
|
4 Participants
|
|
Number of Participants Reporting Comfort Compared to Their Usual Mask.
Same
|
9 Participants
|
|
Number of Participants Reporting Comfort Compared to Their Usual Mask.
Worse
|
6 Participants
|
|
Number of Participants Reporting Comfort Compared to Their Usual Mask.
Much Worse
|
1 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days In-HomeDetermined from data recorded from the PAP device to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Nasal
n=37 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
.
|
|---|---|
|
Number of Participants PAP Device Performance Reporting
Better than usual mask
|
9 Participants
|
|
Number of Participants PAP Device Performance Reporting
Same as usual mask
|
13 Participants
|
|
Number of Participants PAP Device Performance Reporting
Worse than usual mask
|
2 Participants
|
|
Number of Participants PAP Device Performance Reporting
No data
|
13 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days In-HomePerformance reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Nasal
n=37 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
.
|
|---|---|
|
Number of Participants Subjective Performance Rating of the Nasal Mask
Very good
|
23 Participants
|
|
Number of Participants Subjective Performance Rating of the Nasal Mask
Good
|
6 Participants
|
|
Number of Participants Subjective Performance Rating of the Nasal Mask
Acceptable
|
4 Participants
|
|
Number of Participants Subjective Performance Rating of the Nasal Mask
Poor
|
4 Participants
|
|
Number of Participants Subjective Performance Rating of the Nasal Mask
Very Poor
|
0 Participants
|
PRIMARY outcome
Timeframe: During Visit Two - 20 minutesUsability reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Nasal
n=37 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
.
|
|---|---|
|
Number of Participants Subjective Reporting of Nasal Mask Usability
Very Easy
|
23 Participants
|
|
Number of Participants Subjective Reporting of Nasal Mask Usability
Easy
|
9 Participants
|
|
Number of Participants Subjective Reporting of Nasal Mask Usability
Acceptable
|
5 Participants
|
|
Number of Participants Subjective Reporting of Nasal Mask Usability
Difficult
|
0 Participants
|
|
Number of Participants Subjective Reporting of Nasal Mask Usability
Very Difficult
|
0 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days In-HomeEase of use reported from participants questionnaires to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Nasal
n=37 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
.
|
|---|---|
|
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Very Easy
|
23 Participants
|
|
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Easy
|
9 Participants
|
|
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Acceptable
|
5 Participants
|
|
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Difficult
|
0 Participants
|
|
Number of Participants Subjective Recording of Ease of Nasal Mask Use.
Very Difficult
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 ± 5 days In-HomeLeak data recorded from PAP device to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Nasal
n=37 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
.
|
|---|---|
|
Number of Participants Leak Compared to Usual Mask
Better than current mask
|
9 Participants
|
|
Number of Participants Leak Compared to Usual Mask
Same as current mask
|
13 Participants
|
|
Number of Participants Leak Compared to Usual Mask
Worse than current mask
|
2 Participants
|
|
Number of Participants Leak Compared to Usual Mask
No Data
|
13 Participants
|
SECONDARY outcome
Timeframe: 1 day-time appointment (1 hour)Sizing determined from a customized fitting tool to evaluate the use of the F\&P nasal mask for treatment of Obstructive Sleep Apnea
Outcome measures
| Measure |
F&P Nasal
n=37 Participants
Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
.
|
|---|---|
|
Number of Participants With Correct Nasal Mask Size Determination
Correct
|
22 Participants
|
|
Number of Participants With Correct Nasal Mask Size Determination
In between sizes
|
6 Participants
|
|
Number of Participants With Correct Nasal Mask Size Determination
Incorrect
|
9 Participants
|
Adverse Events
F&P Nasal Mask
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