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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44HL158286-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| traditional CPAP Nuance mask users | 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. |
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| DreamPort-Eclipse mask users | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usability | Other | Patients will be observed and asked a serious of questions while they put the mask on and after they remove it. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Each Setup | The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. |
| Number of Technical Issues That Occurred During the Trial | The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask) | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. |
| Number of Times Subjects Needed Additional Instructions | The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask. | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients were regular clients at the SCMT offices in Murfreesboro and Clarksville. SCMT patients who were already adherent CPAP users were asked if they wanted to participate in research.
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Heatherington | Bleep, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AeroFlow Sleep | Asheville | North Carolina | 28803 | United States | ||
| Advanced Respiratory and Sleep Medicine |
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 protected health information (PHI) will be shared. Aggregated participant demographic data will be shared.
Data will become available 4 years after the study completion.
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.
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In this study to evaluate the Bleep Eclipse, SCMT patients who were already adherent CPAP users were asked if they wanted to participate in research.
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| ID | Title | Description |
|---|---|---|
| FG000 | In-House Usability Study Group | Eclipse novel CPAP mask: 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). Phillips Respironics Nuance: 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Patient group already being treated at SCMT. Patients were informed about the study and then volunteered to participate if interested.
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| ID | Title | Description |
|---|---|---|
| BG000 | In-House Usability Study Group | 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. Eclipse novel CPAP mask: 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. Phillips Respironics Nuance: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Complete Each Setup | The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask | Posted | Mean | Standard Deviation | seconds | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. |
|
Adverse events were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
There is some associated risk when completing a clinical trial. The risk for this trial is minimal but is not 0. All 35 participants would have been at risk for a potential adverse event, however, no adverse events were experienced or reported during this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-House Usability Study Group | Eclipse novel CPAP mask: 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). Phillips Respironics Nuance: 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Heatherington, Founder and Executive Chairman of Bleep | Bleep, LLC | (919) 619-7170 | stuart@bleepsleep.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 30, 2022 | Jul 14, 2025 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000086825 | User-Centered Design |
| ID | Term |
|---|---|
| D004867 | Equipment Design |
| D008919 | Investigative Techniques |
| D000080562 | Universal Design |
| D004738 | Engineering |
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| Huntersville |
| North Carolina |
| 98078 |
| United States |
| Sleep Centers of Middle Tennessee | Murfreesboro | Tennessee | 37129 | United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Nuance Traditional 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 tries will be randomized. |
|
|
| Primary | Number of Technical Issues That Occurred During the Trial | The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask) | Posted | Mean | Standard Deviation | issues | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. |
|
|
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| Primary | Number of Times Subjects Needed Additional Instructions | The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask. | Posted | Mean | Standard Deviation | times | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. |
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| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D013676 |
| Technology, Industry, and Agriculture |