Obstructive Sleep Apnea, Sleep Disordered Breathing
Conditions
Brief summary
This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington. Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial. This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.
Interventions
DEVICESaturn nasal mask
Nasal 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 or nasal pillow mask user
Exclusion criteria
* Inability to give consent * Participants who are in a coma or a decreased level of consciousness. * Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure) * 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 | Description |
|---|---|---|
| Noise | Up to 7 ± 3 days in-home | Subjective questionnaire |
| Draft | Up to 7 ± 3 days in-home | Subjective questionnaire |
| Treatment efficacy | Up to 7 ± 3 days in-home | Obtained from participant's CPAP device |
| Comfort | Up to 7 ± 3 days in-home | Subjective questionnaire |
| Stability | Up to 7 ± 3 days in-home | Subjective questionnaire |
| Objective leak data | Up to 7 ± 3 days in-home | Obtained from participant's CPAP device |
| Subjective measurement of leak | Up to 7 ± 3 days in-home | Subjective questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | Up to 7 ± 3 days in-home | Subjective questionnaire |
| Preference of mask | Up to 7 ± 3 days in-home | Subjective questionnaire |
Countries
New Zealand
Outcome results
None listed