Trial Outcomes & Findings for The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea (NCT NCT03726346)
NCT ID: NCT03726346
Last Updated: 2022-06-21
Results Overview
Participant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
14±4 days in home
Results posted on
2022-06-21
Participant Flow
Participant milestones
| Measure |
Toffee Full Face Mask
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
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|---|---|
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Overall Study
STARTED
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39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Toffee Full Face Mask
n=39 Participants
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
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Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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39 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14±4 days in homeParticipant preference for the Toffee mask over their usual mask. Determined from questionnaires -Subjective
Outcome measures
| Measure |
Toffee Full Face Mask
n=39 Participants
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
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|---|---|
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Toffee Mask Acceptability
Preferred Toffee mask
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27 Participants
|
|
Toffee Mask Acceptability
Preferred usual mask
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12 Participants
|
PRIMARY outcome
Timeframe: 14±4 days in homeOverall Toffee mask comfort determined from questionnaires-Subjective
Outcome measures
| Measure |
Toffee Full Face Mask
n=39 Participants
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
|
|---|---|
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Toffee Mask Comfort
Very comfortable
|
15 Participants
|
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Toffee Mask Comfort
Comfortable
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17 Participants
|
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Toffee Mask Comfort
Neither comfortable nor uncomfortable
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3 Participants
|
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Toffee Mask Comfort
Uncomfortable
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4 Participants
|
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Toffee Mask Comfort
Very uncomfortable
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0 Participants
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PRIMARY outcome
Timeframe: 14±4 days in homeSealing performance of Toffee mask determined from questionnaires - Subjective
Outcome measures
| Measure |
Toffee Full Face Mask
n=39 Participants
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
|
|---|---|
|
Toffee Mask Treatment Seal Performance-Subjective
Very good
|
14 Participants
|
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Toffee Mask Treatment Seal Performance-Subjective
Good
|
14 Participants
|
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Toffee Mask Treatment Seal Performance-Subjective
Neither good nor poor
|
9 Participants
|
|
Toffee Mask Treatment Seal Performance-Subjective
Poor
|
2 Participants
|
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Toffee Mask Treatment Seal Performance-Subjective
Very poor
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0 Participants
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SECONDARY outcome
Timeframe: 14±4 days in homeObjective Apnea Hypopnea Index (AHI) data recorded from the participants Positive Airway Pressure (PAP) device and compared to baseline AHI data - Objective
Outcome measures
| Measure |
Toffee Full Face Mask
n=39 Participants
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
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|---|---|
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Toffee Mask Treatment Performance-Objective
AHI decreased
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19 Participants
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Toffee Mask Treatment Performance-Objective
AHI increased
|
10 Participants
|
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Toffee Mask Treatment Performance-Objective
N/A
|
10 Participants
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Adverse Events
Toffee Full Face Mask
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Toffee Full Face Mask
n=39 participants at risk
Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
Toffee Full Face Mask: Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
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|---|---|
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Skin and subcutaneous tissue disorders
Cheek pressure/ discomfort
|
10.3%
4/39 • Number of events 4 • Adverse event data was collected for all participants for 1 year from the date informed consent was obtained.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place