Obstructive Sleep Apnea, Sleep Disordered Breathing
Conditions
Brief summary
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask.
Detailed description
The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher & Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand. The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.
Interventions
DEVICEAlternative sizing model based trial mask
A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.
DEVICEPrototype Full Face Mask
A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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 * Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night * Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis * Existing nasal or full face 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 (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 |
|---|---|---|
| Seal Comfort | Up to 3 weeks in-home | Obtained from subjective questionnaire |
| Subjective Seal Leak | Up to 3 weeks in-home | Obtained from subjective questionnaire |
| Objective Seal Leak | Up to 3 weeks in-home | Measured by device data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective correct mask selection | Up to 3 weeks in-home | Measured by device leak data |
| Subjective correct mask selection | Up to 3 weeks in-home | Measured by subjective questionnaire |
Countries
New Zealand
Outcome results
None listed