Obstructive Sleep Apnea
Conditions
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.
Interventions
OTHERUsability
Patients will be observed and asked a serious of questions while they put the mask on and after they remove it.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Bleep, LLC
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Each Setup | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. | The estimated time that it takes every subject to place the mask on their faces. Average of 3 trials per mask |
| Number of Technical Issues That Occurred During the Trial | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. | The total number of technical issues that the subject encountered while trying on either mask (average of 3 trials per mask) |
| Number of Times Subjects Needed Additional Instructions | Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use. | The amount of times that the subject needed help from the technician when placing either on either mask. Average of 3 trials per mask. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | In-House Usability Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black | 11 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants |
| Race/Ethnicity, Customized White | 15 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
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)
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eclipse Novel CPAP Mask | Number of Technical Issues That Occurred During the Trial | 6 issues | Standard Deviation 1 |
| Nuance Traditional Mask | Number of Technical Issues That Occurred During the Trial | 15 issues | Standard Deviation 3.4 |
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.
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eclipse Novel CPAP Mask | Number of Times Subjects Needed Additional Instructions | 3.7 times | Standard Deviation 3.8 |
| Nuance Traditional Mask | Number of Times Subjects Needed Additional Instructions | 0 times | Standard Deviation 0 |
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
Time frame: Outcomes were assessed on the day of use and only during usage, an average of 20-110 seconds per mask use.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eclipse Novel CPAP Mask | Time to Complete Each Setup | 72.9 seconds | Standard Deviation 26.5 |
| Nuance Traditional Mask | Time to Complete Each Setup | 14.6 seconds | Standard Deviation 4.8 |