The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Not Applicable
Completed
- Conditions
- Sleep Disordered BreathingObstructive Sleep Apnea
- Registration Number
- NCT03092921
- Lead Sponsor
- Fisher and Paykel Healthcare
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Acceptability 2 weeks in home Subjective questionnaire
Ease of use 2 weeks in home Subjective questionnaire
- Secondary Outcome Measures
Name Time Method Objective leak data 1 week in home Obtained from participants' device
Trial Locations
- Locations (1)
Fisher & Paykel Healthcare
🇳🇿Auckland, New Zealand
Fisher & Paykel Healthcare🇳🇿Auckland, New Zealand