Back to resultsSleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
Primary Purpose
Obstructive Sleep Apnea
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eclipse novel CPAP mask
ResMed P-10 mask
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- Sleep Centers of Middle TennesseeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eclipse novel mask
Traditional CPAP mask
Arm Description
Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
Outcomes
Primary Outcome Measures
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.
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.
CPAP Device Pressure
CPAP device pressure is expected to decrease with decrease leak with the novel mask.
Secondary Outcome Measures
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.
Mask Acceptance
Mask acceptance will be defined by continued use versus discontinued use
Full Information
NCT ID
NCT05818540
First Posted
April 4, 2023
Last Updated
August 7, 2023
Sponsor
Bleep, LLC
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05818540
Brief Title
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
Official Title
Randomized Controlled Trial to Compare Effectiveness of DreamPort-Eclipse to a Traditional Nasal Mask
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bleep, LLC
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Data collected will be deidentified upon collection - surveys and assessment forms will be labelled with a numerical identifier.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eclipse novel mask
Arm Type
Experimental
Arm Description
Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.
Arm Title
Traditional CPAP mask
Arm Type
Active Comparator
Arm Description
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
Intervention Type
Device
Intervention Name(s)
Eclipse novel CPAP mask
Intervention Description
Participants will wear the mask for 6 hours a night for 60 days.
Intervention Type
Device
Intervention Name(s)
ResMed P-10 mask
Intervention Description
Participants will wear the mask for 6 hours a night for 60 days.
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index (AHI)
Description
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.
Time Frame
60 days
Title
Leak
Description
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.
Time Frame
60 days
Title
CPAP Device Pressure
Description
CPAP device pressure is expected to decrease with decrease leak with the novel mask.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Participant satisfaction with the mask choice:
Description
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.
Time Frame
60 days
Title
Mask Acceptance
Description
Mask acceptance will be defined by continued use versus discontinued use
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stuart Heatherington
Phone
919-619-7170
Email
clinicaltrials@bleepsleep.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Heatherington
Organizational Affiliation
Bleep, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sleep Centers of Middle Tennessee
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Noah, MD
Phone
615-893-4896
Email
whnoah@sleepcenterinfo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data collected through surveys will be available upon request to the principal investigator. Data requested will be de-identified. Only de-identified data will be made available. Only survey responses and the investigators' observational notes, also deidentified, will be shared. No PHI will be shared. Aggregated participant demographic data will be shared.
IPD Sharing Time Frame
Data will become available 4 years after the study completion.
IPD Sharing Access Criteria
Requests will be made in writing, to the PI, at stuart@bleepsleep.com. Requests should include the reason for the request, how the data is intended to be used, and additional information may be requested. Data will be shared with credentialed, licensed, or otherwise verifiable researchers/investigators for research purposes only.
Learn more about this trial
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
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