Trial Outcomes & Findings for Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask (NCT NCT05818540)
NCT ID: NCT05818540
Last Updated: 2025-11-10
Results Overview
AHI recorded from the software built-in algorithm. The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation.
COMPLETED
NA
173 participants
60 days
2025-11-10
Participant Flow
Newly diagnosed OSA patients, were recruited from SCMT centers.
Participant milestones
| Measure |
Traditional CPAP Mask
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
ResMed P-10 mask: Participants will wear the mask for 6 hours a night for 60 days.
|
Eclipse Novel Mask
Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
Eclipse novel CPAP mask: Participants will wear the mask for 6 hours a night for 60 days.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
74
|
|
Overall Study
COMPLETED
|
54
|
30
|
|
Overall Study
NOT COMPLETED
|
45
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
Baseline characteristics by cohort
| Measure |
Eclipse Novel Mask
n=30 Participants
Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
Eclipse novel CPAP mask: Participants will wear the mask for 6 hours a night for 60 days.
|
Traditional CPAP Mask
n=54 Participants
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
ResMed P-10 mask: Participants will wear the mask for 6 hours a night for 60 days.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
53 Participants
n=20 Participants
|
83 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 9.5 • n=20 Participants
|
47.8 years
STANDARD_DEVIATION 10.2 • n=40 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
24 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
30 Participants
n=20 Participants
|
46 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Completed participants · White
|
19 Participants
n=5 Participants
|
43 Participants
n=20 Participants
|
62 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Completed participants · Black
|
10 Participants
n=5 Participants
|
7 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Completed participants · Hispanic
|
1 Participants
n=5 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Completed participants · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial.
AHI recorded from the software built-in algorithm. The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation.
Outcome measures
| Measure |
Eclipse Novel Mask
n=30 Participants
Human subjects used the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
|
Traditional CPAP Mask
n=54 Participants
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
|
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
|
2.7 events/h
Standard Deviation 3.3
|
2.5 events/h
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial.
Data were captured from the device in L/min at 60 days. Leak is how much flow in L exits the mask while the patient wears it each min. It is recorded through proprietary algorithm undisclosed to the public by the device
Outcome measures
| Measure |
Eclipse Novel Mask
n=30 Participants
Human subjects used the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
|
Traditional CPAP Mask
n=54 Participants
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
|
|---|---|---|
|
Leak
|
3.66 L/min
Standard Deviation 5.38
|
3.01 L/min
Standard Deviation 3.36
|
PRIMARY outcome
Timeframe: 60 daysPopulation: Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial.
Therapeutic positive pressure (in cmH2O) that the device administer for 95% of the night. It is recorded through proprietary algorithm undisclosed to the public by the device.
Outcome measures
| Measure |
Eclipse Novel Mask
n=30 Participants
Human subjects used the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
|
Traditional CPAP Mask
n=54 Participants
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
|
|---|---|---|
|
CPAP Device Pressure (P95)
|
8.93 cmH2O
Standard Deviation 1.01
|
8.62 cmH2O
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial.
A 16-item patient survey was administered to the participants in each arm at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). This reflects the average of all the answered items. For example, question number one had an average score of 4.48 for the eclipse mask arm and 4.12 for the standard mask arm, question number 2 had an average score of 4.40 for the eclipse mask arm and 4.42 for the standard mask arm, etc. Since all questions reflect participant satisfaction, they were averaged to provide an overall score.
Outcome measures
| Measure |
Eclipse Novel Mask
n=30 Participants
Human subjects used the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
|
Traditional CPAP Mask
n=54 Participants
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
|
|---|---|---|
|
Participant Satisfaction With the Mask Choice
|
4.3 score
Standard Deviation 0.4
|
4.1 score
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 60 daysPopulation: Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial.
We estimated the mask tolerability as follows (as a percentage): 100\*(participants who completed the trial) / \[(participants who completed the trial) + (participants who discontinued the trial due to a desire to switch masks or poor mask compliance)\].
Outcome measures
| Measure |
Eclipse Novel Mask
n=30 Participants
Human subjects used the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
|
Traditional CPAP Mask
n=54 Participants
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
|
|---|---|---|
|
Percentage of Participants Who Could Tolerate the Mask Well (Mask Tolerability)
|
41 % of enrolled participants
|
55 % of enrolled participants
|
Adverse Events
Eclipse Novel Mask
Traditional CPAP Mask
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