Trial Outcomes & Findings for The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea (NCT NCT03230877)
NCT ID: NCT03230877
Last Updated: 2022-09-08
Results Overview
Overall seal comfort determined from questionnaires- Subjective
Recruitment status
COMPLETED
Target enrollment
38 participants
Primary outcome timeframe
7 ± 4 days in-home
Results posted on
2022-09-08
Participant Flow
Participant milestones
| Measure |
Normal Seal Then Improved Seal
Participants will be randomized to the Normal Seal arm for a total of 7 ± 4 days from visit 1 and then will be crossed over to the Improved Seal arm for a total of 7 ± 4 days from visit 2.
|
Improved Seal Then Normal Seal
Participants will be randomized to the Improved Seal arm for a total of 7 ± 4 days from visit 1 and then will be crossed over to the Normal Seal arm for a total of 7 ± 4 days from visit 2.
|
|---|---|---|
|
Visit 1
STARTED
|
23
|
15
|
|
Visit 1
COMPLETED
|
23
|
15
|
|
Visit 1
NOT COMPLETED
|
0
|
0
|
|
Visit 2
STARTED
|
23
|
15
|
|
Visit 2
COMPLETED
|
23
|
15
|
|
Visit 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Overall Population
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 ± 4 days in-homeOverall seal comfort determined from questionnaires- Subjective
Outcome measures
| Measure |
Toffee Full Face Mask With 'Improved Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
|
Toffee Full Face Mask With 'Normal Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
|
|---|---|---|
|
Trial Mask Seal Comfort
Very comfortable
|
16 Participants
|
13 Participants
|
|
Trial Mask Seal Comfort
Comfortable
|
16 Participants
|
19 Participants
|
|
Trial Mask Seal Comfort
Neither comfortable nor uncomfortable
|
2 Participants
|
1 Participants
|
|
Trial Mask Seal Comfort
Uncomfortable
|
3 Participants
|
3 Participants
|
|
Trial Mask Seal Comfort
Very uncomfortable
|
0 Participants
|
1 Participants
|
|
Trial Mask Seal Comfort
N/A
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 14 ± 4 days in-homePreference for trial mask determined from questionnaires at the end of the trial - Subjective
Outcome measures
| Measure |
Toffee Full Face Mask With 'Improved Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
|
Toffee Full Face Mask With 'Normal Seal'
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
|
|---|---|---|
|
Trial Mask Seal Acceptability
N/A
|
1 Participants
|
—
|
|
Trial Mask Seal Acceptability
Preferred "Improved seal"
|
19 Participants
|
—
|
|
Trial Mask Seal Acceptability
Preferred "Normal seal"
|
15 Participants
|
—
|
|
Trial Mask Seal Acceptability
No preference
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 7 ± 4 days in-homeObjective Apnea Hypopnea Index (AHI) data recorded from Positive airway pressure (PAP) device, compared to baseline AHI data
Outcome measures
| Measure |
Toffee Full Face Mask With 'Improved Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
|
Toffee Full Face Mask With 'Normal Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
|
|---|---|---|
|
Trial Mask Seal Treatment Performance - Objective
Increased AHI
|
10 Participants
|
6 Participants
|
|
Trial Mask Seal Treatment Performance - Objective
No change in AHI
|
3 Participants
|
4 Participants
|
|
Trial Mask Seal Treatment Performance - Objective
Decreased AHI
|
7 Participants
|
11 Participants
|
|
Trial Mask Seal Treatment Performance - Objective
N/A
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 1 hour day-time appointmentUsability interview during first visit- Subjective
Outcome measures
| Measure |
Toffee Full Face Mask With 'Improved Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
|
Toffee Full Face Mask With 'Normal Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
|
|---|---|---|
|
Trial Mask Seal Usability
Very easy
|
28 Participants
|
26 Participants
|
|
Trial Mask Seal Usability
Easy
|
8 Participants
|
7 Participants
|
|
Trial Mask Seal Usability
Neither easy nor difficult
|
0 Participants
|
2 Participants
|
|
Trial Mask Seal Usability
Difficult
|
0 Participants
|
1 Participants
|
|
Trial Mask Seal Usability
Very difficult
|
0 Participants
|
0 Participants
|
|
Trial Mask Seal Usability
N/A
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 7 ± 4 days in-homeSeal performance determined from questionnaires - Subjective
Outcome measures
| Measure |
Toffee Full Face Mask With 'Improved Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Improved Seal' in this treatment arm.
Toffee full face mask with 'Improved Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.
|
Toffee Full Face Mask With 'Normal Seal'
n=38 Participants
Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1 and then crossed over to the other arm. Participants will be using a full face mask with the 'Normal Seal' in this treatment arm.
Toffee full face mask with 'Normal Seal': Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.
|
|---|---|---|
|
Trial Mask Seal Treatment Performance- Subjective
Very poor
|
1 Participants
|
2 Participants
|
|
Trial Mask Seal Treatment Performance- Subjective
N/A
|
1 Participants
|
1 Participants
|
|
Trial Mask Seal Treatment Performance- Subjective
Very good
|
19 Participants
|
17 Participants
|
|
Trial Mask Seal Treatment Performance- Subjective
Good
|
11 Participants
|
12 Participants
|
|
Trial Mask Seal Treatment Performance- Subjective
Neither good nor poor
|
3 Participants
|
4 Participants
|
|
Trial Mask Seal Treatment Performance- Subjective
Poor
|
3 Participants
|
2 Participants
|
Adverse Events
Toffee Full Face Mask With 'Improved Seal'
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Toffee Full Face Mask With 'Normal Seal'
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