Obstructive Sleep Apnea, Sleep Disordered Breathing
Conditions
Brief summary
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.
Detailed description
A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week. An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.
Interventions
DEVICEF&P Mask Seal
Investigative Mask Seal to be used for OSA therapy
DEVICEF&P Mask
Investigative Mask to be used for OSA therapy
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NON_RANDOMIZED
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 * Apnea hypopnea Index (AHI)≥ 5 on diagnostic night * Prescribed PAP for OSA * Existing oro-nasal 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 automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure) * Commercial drivers who are investigated by New Zealand Transport Agency * Current diagnosis of carbon dioxide (CO2) retention * Pregnant or may think they are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ease of use | 1 week in home | Subjective questionnaire |
| Acceptability | 1 week in home | Subjective questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective leak data | 1 week in home | Obtained from participants' device |
Countries
New Zealand
Outcome results
None listed