The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- Trial Mask Seal Acceptability
Study Overview
Brief Summary
The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site
Detailed Description
This study will involve three visits to the investigation site. During visit one participants will be randomized to, fitted with and issued with the first trial mask seal for use in- home for 7 ±4 days.
The participants will then come in to return the mask seal and be fitted and issued with the second trial seal for use in home for 7±4 days.
Visit Three will involve the participants returning the second trial seal and providing feedback.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (22+ years of age)
- •Able to give informed consent
- •Apnea hypopnea Index (AHI) ≥ 5 on diagnostic night
- •Either prescribed Automatic positive airway pressure (APAP), Continuous positive airway pressure (CPAP) or Bi-level positive airway pressure (PAP) for OSA
- •Fluent in spoken and written English
- •Existing F&P full face mask user
Exclusion Criteria
- •Inability to give informed consent
- •Participant intolerant to PAP
- •Anatomical or physiological conditions making PAP therapy inappropriate
- •Current diagnosis of respiratory disease or carbon Dioxide (CO2) retention
- •Pregnant or may think they are pregnant.
Outcomes
Primary Outcomes
Trial Mask Seal Acceptability
Time Frame: 14 ± 4 days in-home
Preference for trial mask determined from questionnaires at the end of the trial - Subjective
Trial Mask Seal Comfort
Time Frame: 7 ± 4 days in-home
Overall seal comfort determined from questionnaires- Subjective
Secondary Outcomes
- Trial Mask Seal Usability(1 hour day-time appointment)
- Trial Mask Seal Treatment Performance - Objective(7 ± 4 days in-home)
- Trial Mask Seal Treatment Performance- Subjective(7 ± 4 days in-home)