Obstructive Sleep Apnea
Conditions
Brief summary
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.
Detailed description
Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.
Interventions
DEVICEHeadgear
Investigative Headgear with CPAP Mask.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* AHI≥5 from the diagnostic night * ≥18 years of age * Prescribed CPAP or Bilevel therapy for OSA * Existing CPAP mask users
Exclusion criteria
* Inability to give informed consent * Patient intolerant to PAP * Anatomical or physiological conditions making PAP therapy inappropriate * History of respiratory disease or CO2 retention. * Pregnant or think they may be pregnant * Investigated by Land Transport Safety Authority
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants perception of the headgear on mask performance | 2-4 weeks | Assess if the headgear with mask changes the perception of the performance of the mask. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that choose this Headgear over their usual. | 2-4 weeks | Assess the acceptability of the headgear with mask. |
Countries
New Zealand
Outcome results
None listed