Obstructive Sleep Apnea, Sleep Disordered Breathing
Conditions
Brief summary
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.
Detailed description
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects with OSA (Ethics reference NTY/08/06/064), Auckland District Health Board (ADHB), or WellSleep Centre (Bowen Hospital, Wellington, NZ). Participants will be on the trial for 21 days ± 6 days, using the prototypes at home for 14 days ± 3 days. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for 7 days ± 3 days prior to mask fitting with the Jupiter trial mask. Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. 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 (Bhavi Ogra) as soon as possible.
Interventions
DEVICEJupiter Full Face Mask
Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.
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
* 18+ years of age * Diagnosed with OSA by a practicing physician * Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more) * Existing full face mask users * Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands).
Exclusion criteria
* Inability to give informed consent * Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture) * Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA) * Current diagnosis of CO2 retention * Pregnant or think they may be pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Noise assessed using a Subjective Questionnaire | Up to 21 ± 6 days in-home | Subjective Questionnaire |
| Stability assessed using a Subjective Questionnaire | Up to 21 ± 6 days in-home | Subjective Questionnaire |
| Draft assessed using a Subjective Questionnaire | Up to 21 ± 6 days in-home | Subjective Questionnaire |
| Objective mask leak data measurement (System Leak) | Up to 21 ± 6 days in-home | Obtained from participant's CPAP device, measured in L/min |
| Subjective Measurement of leak assessed using a Subjective Questionnaire | Up to 21 ± 6 days in-home | Subjective Questionnaire |
| Comfort assessed using a Subjective Questionnaire | Up to 21 ± 6 days in-home | Subjective Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability via mask unboxing/fitting exercise with a subjective questionnaire | Up to 21 ± 6 days in-home | Usability activity during visit 2 with subjective questionnaire after activity |
| Preference of Mask assessed using a Subjective Questionnaire | Up to 21 ± 6 days in-home | Subjective Questionnaire |
Countries
New Zealand
Outcome results
None listed