Trial Outcomes & Findings for The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (NCT NCT03242148)
NCT ID: NCT03242148
Last Updated: 2021-09-22
Results Overview
Questionnaire on usability during second visit - Subjective. Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.
COMPLETED
NA
38 participants
14 ± 5 days in-Home
2021-09-22
Participant Flow
Participant milestones
| Measure |
Toffee Nasal Pillows Mask
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Toffee Nasal Pillows Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
|
|---|---|
|
Age, Customized
22-35
|
0 Participants
n=5 Participants
|
|
Age, Customized
36-45
|
5 Participants
n=5 Participants
|
|
Age, Customized
46-55
|
3 Participants
n=5 Participants
|
|
Age, Customized
56-65
|
10 Participants
n=5 Participants
|
|
Age, Customized
66-75
|
14 Participants
n=5 Participants
|
|
Age, Customized
76-85
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
38 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-HomeQuestionnaire on usability during second visit - Subjective. Participants rated overall usability of the mask on a 5 point likert type scale ranging from very easy, easy, neither, difficult or very difficult.
Outcome measures
| Measure |
Toffee Nasal Pillows Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
|
|---|---|
|
Toffee Mask Usability
Rating Very easy or easy
|
33 Participants
|
|
Toffee Mask Usability
Rating very difficult or difficult
|
1 Participants
|
|
Toffee Mask Usability
Rating Neither
|
4 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-HomeDetermine from questionnaires - Subjective Participants rated overall comfort of the mask by indicating on a 5 point likert type scale the degree of comfort they felt. Answer responses ranges from very good, good, neither, poor, or very poor
Outcome measures
| Measure |
Toffee Nasal Pillows Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
|
|---|---|
|
Toffee Mask Comfort
Rated very good or good
|
31 Participants
|
|
Toffee Mask Comfort
Very poor, poor
|
2 Participants
|
|
Toffee Mask Comfort
Neither
|
5 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-HomeDetermined from questionnaires - Subjective Participants rated overall performance of the mask on a 5 point likert type scale with responses including very good, good, neither, poor, or very poor
Outcome measures
| Measure |
Toffee Nasal Pillows Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
|
|---|---|
|
Toffee Mask Treatment Performance - Subjective
Rated very good or good
|
30 Participants
|
|
Toffee Mask Treatment Performance - Subjective
Rated poor or very poor
|
4 Participants
|
|
Toffee Mask Treatment Performance - Subjective
Rated neither
|
4 Participants
|
PRIMARY outcome
Timeframe: 14 ± 5 days in-HomeParticipant count regarding whether they would continue using the trial mask if given the choice.
Outcome measures
| Measure |
Toffee Nasal Pillows Mask
n=38 Participants
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
|
|---|---|
|
Trial Mask Acceptability
Yes
|
27 Participants
|
|
Trial Mask Acceptability
No
|
11 Participants
|
SECONDARY outcome
Timeframe: 14 ± 5 days in-HomePopulation: 4 data sets were unavailable for analysis
Objective data recorded from PAP device - Objective Apnea hypopnea index (AHI) data extracted from participants therapy efficacy reports was used to assess this outcome. AHI is a measure of disease severity and is used to evaluate treatment efficacy. Data was reported as a "pass" or "fail" based on the change in AHI from baseline to the intervention. If AHI increased by a clinically significant amount (as reviewed by the PI/study staff) this was marked as a fail.
Outcome measures
| Measure |
Toffee Nasal Pillows Mask
n=34 Participants
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
|
|---|---|
|
Toffee Mask Treatment Performance - Objective
Pass
|
34 Participants
|
|
Toffee Mask Treatment Performance - Objective
Fail
|
0 Participants
|
Adverse Events
Toffee Nasal Pillows Mask
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Toffee Nasal Pillows Mask
n=38 participants at risk
Participants will be placed on this arm for a total of 14 +- 5 days from visit 2. participants will be using the Toffee mask during this treatment arm
Toffee Nasal Pillows Mask: Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Nasal Irritation
|
18.4%
7/38 • Number of events 7 • Adverse events were collected for all participants for 1 year from the date informed consent was obtained.
|
|
Skin and subcutaneous tissue disorders
Sore on the top of the head
|
2.6%
1/38 • Number of events 1 • Adverse events were collected for all participants for 1 year from the date informed consent was obtained.
|
Additional Information
Clinical Research Scientist
Fisher and Paykel Healthcare
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER