Trial Outcomes & Findings for Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device (NCT NCT05570747)
NCT ID: NCT05570747
Last Updated: 2025-11-10
Results Overview
The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask.
Recruitment status
COMPLETED
Target enrollment
35 participants
Primary outcome timeframe
Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
Results posted on
2025-11-10
Participant Flow
In this study to evaluate the Bleep Eclipse, SCMT patients who were already adherent CPAP users were asked if they wanted to participate in research.
Participant milestones
| Measure |
In-House Usability Study Group
Eclipse novel CPAP mask: Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
Phillips Respironics Nuance: Participants will follow instructions to set up and put on the Respironics Nuance, traditional nasal mask. Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Traditional CPAP Mask
|
35
|
|
Overall Study
Eclipse Novel CPAP Mask
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Simulated In-House Usability Study of Eclipse Continuous Positive Airway Pressure (CPAP) Device
Baseline characteristics by cohort
| Measure |
In-House Usability Study Group
n=35 Participants
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
Eclipse novel CPAP mask: Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
Phillips Respironics Nuance: Participants will follow instructions to set up and put on the Respironics Nuance, traditional nasal mask. Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask
Outcome measures
| Measure |
Eclipse Novel CPAP Mask
n=35 Participants
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
Eclipse novel CPAP mask: Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
|
Nuance Traditional Mask
n=35 Participants
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
|
|---|---|---|
|
Time to Complete Each Setup
|
72.9 seconds
Standard Deviation 26.5
|
14.6 seconds
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask)
Outcome measures
| Measure |
Eclipse Novel CPAP Mask
n=35 Participants
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
Eclipse novel CPAP mask: Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
|
Nuance Traditional Mask
n=35 Participants
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
|
|---|---|---|
|
Number of Technical Issues That Occurred During the Trial
|
6 issues
Standard Deviation 1
|
15 issues
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask.
Outcome measures
| Measure |
Eclipse Novel CPAP Mask
n=35 Participants
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
Eclipse novel CPAP mask: Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring).
Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
|
Nuance Traditional Mask
n=35 Participants
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
|
|---|---|---|
|
Number of Times Subjects Needed Additional Instructions
|
3.7 times
Standard Deviation 3.8
|
0 times
Standard Deviation 0
|
Adverse Events
In-House Usability Study Group
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
Stuart Heatherington, Founder and Executive Chairman of Bleep
Bleep, LLC
Phone: (919) 619-7170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place