Investigative Headgear With CPAP Mask
Not Applicable
Completed
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: Headgear
- Registration Number
- NCT02323035
- Lead Sponsor
- Fisher and Paykel Healthcare
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Headgear Headgear Investigative Headgear with CPAP Mask.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of participants that choose this Headgear over their usual. 2-4 weeks Assess the acceptability of the headgear with mask.
Trial Locations
- Locations (1)
Fisher & Paykel Healthcare
🇳🇿Auckland, New Zealand