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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Eclipse novel CPAP mask
* Device: ResMed P-10 mask


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eclipse novel mask<br>Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night. | Device: Eclipse novel CPAP mask<br>* Participants will wear the mask for 6 hours a night for 60 days.<br>|
| Active Comparator: Traditional CPAP mask<br>Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night. | Device: ResMed P-10 mask<br>* Participants will wear the mask for 6 hours a night for 60 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | 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. For OSA treatment, we are looking to see AHI decrease to <5. | 60 days | 
| Leak | Leak can be caused by several issues- having the wrong mask size or type, the mask not being assembled or fitted correctly, or parts being worn out and needing replacement. The acceptable leak rate is up to 24 litres per minute. Anything below this means the patient is still getting the full benefits of therapy. | 60 days | 
| CPAP Device Pressure | CPAP device pressure is expected to decrease with decrease leak with the novel mask. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant satisfaction with the mask choice: | Survey title: Bleep Sleep (BSL)-SNAP-003 Participant Survey Satisfaction will be based on a participant questionnaire in which they indicate their overall satisfaction with the mask they are assigned.Lower score indicates higher patient satisfaction. Scale is as follows: Strongly disagree, Disagree, Neither agree or disagree, Agree, Strongly Agree. | 60 days | 
| Mask Acceptance | Mask acceptance will be defined by continued use versus discontinued use | 60 days |