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
DEVICEEclipse mask
Users will interact with the Eclipse CPAP machine and report on usability/likeability.
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 |
|---|---|---|
| Number of Participants Who Asked for Additional Information | Throughout the duration of the study (48 hours) | The total count of participants who asked for additional information during the course of home use of the mask was recorded |
| Mask Likeability | At 48 hours | 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. |
| Number of Participants Who Experienced Technical Issues | The duration of the trial (48 h) | Total count of participants who reported technical issues during the course of the 48 h home use of the mask were recorded |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| Total | 70 |
Baseline characteristics
| Characteristic | Eclipse Mask (Single Arm Study) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants |
| Race/Ethnicity, Customized Asian | 7 participants |
| Race/Ethnicity, Customized Black | 26 participants |
| Race/Ethnicity, Customized Hispanic | 14 participants |
| Race/Ethnicity, Customized White | 23 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
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.
Time frame: At 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eclipse Novel CPAP Mask | Mask Likeability | 4.1 score | Standard Deviation 0.4 |
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
Time frame: Throughout the duration of the study (48 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eclipse Novel CPAP Mask | Number of Participants Who Asked for Additional Information | 6 Participants |
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
Time frame: The duration of the trial (48 h)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eclipse Novel CPAP Mask | Number of Participants Who Experienced Technical Issues | 7 Participants |