Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask

Randomized Controlled Trial to Compare Effectiveness of DreamPort-Eclipse to a Traditional Nasal Mask

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05818540

Enrollment

173

Registered

2023-04-19

Start date

2023-04-17

Completion date

2023-12-29

Last updated

2025-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief summary

The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure compared to a traditional nasal mask.

Interventions

DEVICEEclipse novel CPAP mask

Participants will wear the mask for 6 hours a night for 60 days.

DEVICEResMed P-10 mask

Participants will wear the mask for 6 hours a night for 60 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Data collected will be deidentified upon collection - surveys and assessment forms will be labelled with a numerical identifier.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

• Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device

Exclusion criteria

* Any medical or behavioral conditions that would compromise subject safety * Under the age of 18 years old

Design outcomes

Primary

Measure	Time frame	Description
Apnea-Hypopnea Index (AHI)	60 days	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.
Leak	60 days	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
CPAP Device Pressure (P95)	60 days	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.

Secondary

Measure	Time frame	Description
Participant Satisfaction With the Mask Choice	60 days	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.
Percentage of Participants Who Could Tolerate the Mask Well (Mask Tolerability)	60 days	We estimated the mask tolerability as follows (as a percentage): 100\*(participants who completed the trial) / \[(participants who completed the trial) + (participants who discontinued the trial due to a desire to switch masks or poor mask compliance)\].

Countries

United States

Participant flow

Recruitment details

Newly diagnosed OSA patients, were recruited from SCMT centers.

Participants by arm

Arm	Count
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.	30
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.	54
Total	84

Baseline characteristics

Characteristic	Eclipse Novel Mask	Traditional CPAP Mask	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	1 Participants	1 Participants
Age, Categorical Between 18 and 65 years	30 Participants	53 Participants	83 Participants
Age, Continuous	46.4 years STANDARD_DEVIATION 11.2	58.5 years STANDARD_DEVIATION 9.5	47.8 years STANDARD_DEVIATION 10.2
Race/Ethnicity, Customized Completed participants Asian	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Completed participants Black	10 Participants	7 Participants	17 Participants
Race/Ethnicity, Customized Completed participants Hispanic	1 Participants	4 Participants	5 Participants
Race/Ethnicity, Customized Completed participants White	19 Participants	43 Participants	62 Participants
Sex: Female, Male Female	14 Participants	24 Participants	38 Participants
Sex: Female, Male Male	16 Participants	30 Participants	46 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 30	0 / 54
other Total, other adverse events	0 / 30	0 / 54
serious Total, serious adverse events	0 / 30	0 / 54

Outcome results

Primary

Apnea-Hypopnea Index (AHI)

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.

Time frame: 60 days