Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of the study is to observe the Pilairo mask in a lab setting.
Detailed description
The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.
Interventions
DEVICECPAP mask ( Pilairo)
PROCEDUREOther CPAP mask
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Apnea Hypopnea Indea \>15 from diagnostic study * Minimum 18 years of age
Exclusion criteria
* Inability ot give informed consent * History of intolerance to CPAP * Anatomical or physiological conditions making CPAP therapy inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technician Experience With Mask | One night | Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Mask Interventions During the Night | One night | Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pilairo Pilairo nasal pillows mask during CPAP titration
CPAP mask ( Pilairo) | 50 |
| Other CPAP Mask Other CPAP mask during CPAP titration
Other CPAP mask | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 6 | 13 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Pilairo | Other CPAP Mask | Total |
|---|---|---|---|
| Age, Customized ≥ 18 years | 50 Participants | 50 Participants | 100 Participants |
| Region of Enrollment United States | 50 Participants | 50 Participants | 100 Participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 29 Participants |
| Sex: Female, Male Male | 40 Participants | 31 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Technician Experience With Mask
Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.
Time frame: One night
Population: While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pilairo | Technician Experience With Mask | 8.46 Units on a Scale |
| Other CPAP Mask | Technician Experience With Mask | 8.24 Units on a Scale |
Secondary
Number of Mask Interventions During the Night
Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.
Time frame: One night
Population: While not all participants completed the full study, a number of participants had completed enough of the study to provide data to analyze. For this outcome measure, 48 participants in the Pilairo Group had usable data for analysis while 42 participants in the Other CPAP mask group had usable data for analysis for this measure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pilairo | Number of Mask Interventions During the Night | 1.29 units on a scale |
| Other CPAP Mask | Number of Mask Interventions During the Night | 2.20 units on a scale |