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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
173
Participants will wear the mask for 6 hours a night for 60 days.
Participants will wear the mask for 6 hours a night for 60 days.
Sleep Centers of Middle Tennessee
Murfreesboro, Tennessee, United States
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
Leak
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
Time frame: 60 days
CPAP Device Pressure (P95)
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.
Time frame: 60 days
Participant Satisfaction With the Mask Choice
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.
Time frame: 60 days
Percentage of Participants Who Could Tolerate the Mask Well (Mask Tolerability)
We estimated the mask tolerability as follows (as a percentage): 100\*(participants who completed the trial) / \[(participants who completed the trial) + (participants who discontinued the trial due to a desire to switch masks or poor mask compliance)\].
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Time frame: 60 days