The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
Not Applicable
Completed
- Conditions
- Obstructive Sleep ApneaSleep Disordered Breathing
- Interventions
- Device: F&P nasal mask
- Registration Number
- NCT03156413
- 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 mask.
- Detailed Description
A maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- Adult (18+ years of age)
- Able to give consent
- Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
- Prescribed PAP for OSA
- Existing 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
- Arm && Interventions
Group Intervention Description F&P Nasal Mask F&P nasal mask Trial nasal pillows CPAP mask
- Primary Outcome Measures
Name Time Method Ease of use 1 night Subjective questionnaire
Acceptability 1 night Subjective questionnaire
- Secondary Outcome Measures
Name Time Method Objective leak data 1 night Data obtained from participant's device - Objective
Trial Locations
- Locations (1)
Fisher and Paykel Healthcare
🇳🇿Auckland, New Zealand