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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eclipse novel mask | Experimental | Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night. |
|
| Traditional CPAP mask | Active Comparator | Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eclipse novel CPAP mask | Device | Participants will wear the mask for 6 hours a night for 60 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | AHI recorded from the software built-in algorithm. 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. | 60 days |
| Leak | Data were captured from the device in L/min at 60 days. Leak is how much flow in L exits the mask while the patient wears it each min. It is recorded through proprietary algorithm undisclosed to the public by the device | 60 days |
| CPAP Device Pressure (P95) | Therapeutic positive pressure (in cmH2O) that the device administer for 95% of the night. It is recorded through proprietary algorithm undisclosed to the public by the device. | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction With the Mask Choice | A 16-item patient survey was administered to the participants in each arm at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). This reflects the average of all the answered items. For example, question number one had an average score of 4.48 for the eclipse mask arm and 4.12 for the standard mask arm, question number 2 had an average score of 4.40 for the eclipse mask arm and 4.42 for the standard mask arm, etc. Since all questions reflect participant satisfaction, they were averaged to provide an overall score. |
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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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| Name | Affiliation | Role |
|---|---|---|
| Stuart Heatherington | Bleep, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sleep Centers of Middle Tennessee | Murfreesboro | Tennessee | 37129 | United States |
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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Newly diagnosed OSA patients, were recruited from SCMT centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eclipse Novel Mask | Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night. Eclipse novel CPAP mask: Participants will wear the mask for 6 hours a night for 60 days. |
| FG001 | Traditional CPAP Mask | Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night. ResMed P-10 mask: Participants will wear the mask for 6 hours a night for 60 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eclipse Novel Mask | Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night. Eclipse novel CPAP mask: Participants will wear the mask for 6 hours a night for 60 days. |
| BG001 | Traditional CPAP Mask |
| 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 | Apnea-Hypopnea Index (AHI) | AHI recorded from the software built-in algorithm. 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. | Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial. | Posted | Mean | Standard Deviation | events/h | 60 days |
|
6 months
There were no adverse events reported.
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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 Mask | Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night. Eclipse novel CPAP mask: Participants will wear the mask for 6 hours a night for 60 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Heathington | 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 | Sep 14, 2021 | Mar 13, 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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Data collected will be deidentified upon collection - surveys and assessment forms will be labelled with a numerical identifier.
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| ResMed P-10 mask | Device | Participants will wear the mask for 6 hours a night for 60 days. |
|
| 60 days |
| Percentage of Participants Who Could Tolerate the Mask Well (Mask Tolerability) | We estimated the mask tolerability as follows (as a percentage): 100*(participants who completed the trial) / [(participants who completed the trial) + (participants who discontinued the trial due to a desire to switch masks or poor mask compliance)]. | 60 days |
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night. ResMed P-10 mask: Participants will wear the mask for 6 hours a night for 60 days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night. |
|
|
| Primary | Leak | Data were captured from the device in L/min at 60 days. Leak is how much flow in L exits the mask while the patient wears it each min. It is recorded through proprietary algorithm undisclosed to the public by the device | Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial. | Posted | Mean | Standard Deviation | L/min | 60 days |
|
|
|
| Primary | CPAP Device Pressure (P95) | Therapeutic positive pressure (in cmH2O) that the device administer for 95% of the night. It is recorded through proprietary algorithm undisclosed to the public by the device. | Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial. | Posted | Mean | Standard Deviation | cmH2O | 60 days |
|
|
|
| Secondary | Participant Satisfaction With the Mask Choice | A 16-item patient survey was administered to the participants in each arm at the end of the study. Patients had to answer according to a Likert scale (1: worst, 5:best). This reflects the average of all the answered items. For example, question number one had an average score of 4.48 for the eclipse mask arm and 4.12 for the standard mask arm, question number 2 had an average score of 4.40 for the eclipse mask arm and 4.42 for the standard mask arm, etc. Since all questions reflect participant satisfaction, they were averaged to provide an overall score. | Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial. | Posted | Mean | Standard Deviation | score | 60 days |
|
|
|
| Secondary | Percentage of Participants Who Could Tolerate the Mask Well (Mask Tolerability) | We estimated the mask tolerability as follows (as a percentage): 100*(participants who completed the trial) / [(participants who completed the trial) + (participants who discontinued the trial due to a desire to switch masks or poor mask compliance)]. | Participants who used the Eclipse or P10 mask over a period of 60 days and completed the trial. | Posted | Number | % of enrolled participants | 60 days |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Traditional CPAP Mask | Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night. ResMed P-10 mask: Participants will wear the mask for 6 hours a night for 60 days. | 0 | 54 | 0 | 54 | 0 | 54 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |