Obstructive Sleep Apnea
Conditions
Brief summary
This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.
Interventions
DEVICENew nasal pillows mask with PAP therapy
Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
After the baseline period, all participants will be trialed on the same new nasal pillows mask.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are ≥22 years of age * Weigh ≥66 lbs * Have been formally diagnosed with OSA by a physician * Have an AHI ≥5 on a diagnostic night * Have been prescribed PAP therapy to treat OSA by a physician * Are an existing nasal pillows mask user * Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study * Are compliant with PAP therapy for ≥4 hours per night for 70% of nights * Are fluent in spoken and written English * Possess the capacity to provide informed consent
Exclusion criteria
* Are intolerant to PAP therapy * Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate * Are currently diagnosed with respiratory disease or CO2 retention * Are pregnant or think they may be pregnant * Have an IPAP pressure of \>25 cmH2O * Persons who use a PAP therapy machine for the delivery of medicines, except O2 * Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of new nasal pillows mask | 14±5 days | The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comfort of new nasal pillows mask | 14±5 days | The new nasal pillows mask is comfortable during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire. |
| Usability of new nasal pillows mask | 14±5 days | The new nasal pillows mask is user-friendly during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire. |
Countries
United States
Outcome results
None listed