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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 |
|---|---|---|---|
| In-House Usability Study Group | Seventy adherent CPAP users will volunteer to trial the Eclipse mask for two nights in their homes. Participants who attend an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and will be trained how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night. Participants will follow instructions to set up and put on the Eclipse nasal mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eclipse mask | Device | Users will interact with the Eclipse CPAP machine and report on usability/likeability. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Asked for Additional Information | The total count of participants who asked for additional information during the course of home use of the mask was recorded | Throughout the duration of the study (48 hours) |
| Mask Likeability | A 16-item patient survey was administered to the participants at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). Here, this reflects the average of all the answered items. For example, question number one had an average score of 4.52, question number 2 had an average score of 4.21, etc. Since all questions reflect mask likability, they were averaged to provide an overall score. | At 48 hours |
| Number of Participants Who Experienced Technical Issues | Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded | The duration of the trial (48 h) |
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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:
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Adults over the age of 18 who are CPAP users and attend SCAT centers who volunteer to be in the study.
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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 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, seventy adherent CPAP users volunteered to trial the Eclipse mask for two nights in their homes. Participants attended an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and were trained how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night. No control group was used. Volunteers were gathered from the pool of SCMT participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eclipse Mask Group (Single Arm Study) | A single group was used, namely those trying the Eclipse mask at home for 2 nights |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Seventy adherent CPAP users volunteered to trial the Eclipse mask for two nights in their homes. Participants attended an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and were trained how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night. The volunteers were selected to cover a demographic range of races and gender as required by study sponsor.
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| ID | Title | Description |
|---|---|---|
| BG000 | Eclipse Mask (Single Arm Study) | Seventy adherent CPAP users will volunteer to trial the Eclipse mask for two nights in their homes. Participants who attend an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and will be trained on how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Participant must be 18 years or older. |
| 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 | Number of Participants Who Asked for Additional Information | The total count of participants who asked for additional information during the course of home use of the mask was recorded | Posted | Count of Participants | Participants | Throughout the duration of the study (48 hours) |
|
Participants wore the mask for a 2 night duration and occurrence of adverse events was assessed throughout this time
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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 | Eclipse Novel CPAP Mask | Seventy adherent CPAP users will trial the Eclipse mask for two nights in their homes. Participants who attend an appointment at one of three offices of Sleep Centers of Middle Tennessee (SCMT) and will be trained on how to use the Eclipse mask, then asked to use the Eclipse for two consecutive nights and then complete a participant survey after the second night. No control group was used. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Heatherington | 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 16, 2025 | Prot_SAP_000.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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| Huntersville |
| North Carolina |
| 98078 |
| United States |
| Sleep Centers of Middle Tennessee | Murfreesboro | Tennessee | 37129 | United States |
| Count of Participants |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Mask Likeability | A 16-item patient survey was administered to the participants at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). Here, this reflects the average of all the answered items. For example, question number one had an average score of 4.52, question number 2 had an average score of 4.21, etc. Since all questions reflect mask likability, they were averaged to provide an overall score. | Posted | Mean | Standard Deviation | score | At 48 hours |
|
|
|
| Primary | Number of Participants Who Experienced Technical Issues | Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded | Posted | Count of Participants | Participants | The duration of the trial (48 h) |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |