Obstructive Sleep Apnea
Conditions
Brief summary
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants. Also to assist in the development process it would be beneficial to get feedback from users on certain aspects of the design. The aim of this investigation is to get feedback on the first impressions (look and feel) from users of nasal pillows PAP therapy. A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher & Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI). Participants will undergo an overnight polysomnography session at the Fisher & Paykel Healthcare sleep lab. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.
Interventions
DEVICENew Nasal Pillows Mask
Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (18+ years of age) * Able to give consent * AHI ≥ 5 on diagnostic night * Prescribed a CPAP device after successful OSA diagnosis * Existing nasal pillows mask user
Exclusion criteria
* Inability to give consent * Patients who are in a coma or a decreased level of consciousness. * Anatomical or physiological conditions making APAP therapy inappropriate * Commercial drivers who are investigated by New Zealand Transport Agency (NZTA) * Current diagnosis of CO2 retention * Pregnant or may think they are pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks | 12 hours |
Secondary
| Measure | Time frame |
|---|---|
| Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask | 12 hours |
| Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask | 12 hours |
Countries
New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Toffee Nasal Pillows Mask Participants to use nasal pillows mask one night in lab overnight polysomnography.
Toffee Nasal Pillows Mask: Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA) | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Toffee Nasal Pillows Mask |
|---|---|
| Age, Customized 18+ years of age | 15 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks
Time frame: 12 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Toffee Nasal Pillows Mask | Participants Choose the Toffee Mask Based on First Impressions Over 3 Market Leading Masks | 4 Participants |
Secondary
Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask
Time frame: 12 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Toffee Nasal Pillows Mask | Participants Consider the Toffee Mask to be as Comfortable, or Much More Comfortable Than Their Usual Mask | 9 Participants |
Secondary
Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask
Time frame: 12 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Toffee Nasal Pillows Mask | Participants Consider the Toffee Mask to be Easier or Much Easier to Fit and Adjust Than Their Current Mask | 8 Participants |