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Field Usability Study of Eclipse Mask

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Eclipse novel CPAP mask
Phillips Respironics Nuance
Sponsored by
Bleep, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • Diagnosis of any medical or behavioral conditions that would compromise subject safety.
  • Under the age of 18: target for this current version of the platform is the adult population.

Sites / Locations

  • AeroFlow Sleep
  • Advanced Respiratory and Sleep Medicine
  • Sleep Centers of Middle Tennessee

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

In-House Usability Study Group

Arm Description

Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.

Outcomes

Primary Outcome Measures

Time to complete each setup
We will record the time it takes the participant to set up and try on each device.
Number of technical issues
We will record the number of observed technical issues that occurred when the participant attempts to set up and try on the device.
Number of times participant needs assistance
We will record the number of times each participant requires assistance or additional instructions setting up and trying on each device.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2022
Last Updated
January 25, 2023
Sponsor
Bleep, LLC
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05559047
Brief Title
Field Usability Study of Eclipse Mask
Official Title
Field Usability Study of Eclipse CPAP Device
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)

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 study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.

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
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group 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
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-House Usability Study Group
Arm Type
Experimental
Arm Description
Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device tries will be randomized.
Intervention Type
Device
Intervention Name(s)
Eclipse novel CPAP mask
Intervention Description
Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring). Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
Intervention Type
Device
Intervention Name(s)
Phillips Respironics Nuance
Intervention Description
Participants will follow instructions to set up and put on the Respironics Nuance, traditional nasal mask. Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
Primary Outcome Measure Information:
Title
Time to complete each setup
Description
We will record the time it takes the participant to set up and try on each device.
Time Frame
1 day
Title
Number of technical issues
Description
We will record the number of observed technical issues that occurred when the participant attempts to set up and try on the device.
Time Frame
1 day
Title
Number of times participant needs assistance
Description
We will record the number of times each participant requires assistance or additional instructions setting up and trying on each device.
Time Frame
1 day

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: Diagnosis of any medical or behavioral conditions that would compromise subject safety. Under the age of 18: target for this current version of the platform is the adult population.
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
AeroFlow Sleep
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Advanced Respiratory and Sleep Medicine
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
98078
Country
United States
Facility Name
Sleep Centers of Middle Tennessee
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States

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

Field Usability Study of Eclipse Mask

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