Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT05818540
- Lead Sponsor
- Bleep, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
• Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device
- Any medical or behavioral conditions that would compromise subject safety
- Under the age of 18 years old
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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) / \[(participants who completed the trial) + (participants who discontinued the trial due to a desire to switch masks or poor mask compliance)\].
Trial Locations
- Locations (1)
Sleep Centers of Middle Tennessee
🇺🇸Murfreesboro, Tennessee, United States
Sleep Centers of Middle Tennessee🇺🇸Murfreesboro, Tennessee, United States