A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: F&P Toffee mask
- Registration Number
- NCT03272763
- Lead Sponsor
- Fisher and Paykel Healthcare
- Brief Summary
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
- Detailed Description
This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited.
This study will involve a baseline (Visit One) data gathering with the participant's positive airway pressure (PAP) therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask for use in-home (Visit Two).
The participant then will come in to return the mask (Visit Three) and give their feedback on their experience using the mask in home in the form of a structured interview during Visit Three. The maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from Visit Two.
The mask and CPAP (if used from the research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of their Obstructive Sleep Apnea.
Neither the investigators nor the participants will be blinded to the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- AHI ≥ 5 from the diagnostic night
- Aged 22 and over (FDA defined as default)
- Either prescribed APAP, CPAP or Bi-level PAP for OSA
- Existing Full-Face mask user
- Fluent in spoken and written English
- Inability to give informed consent
- Participant intolerant to PAP
- Anatomical or physiological conditions making PAP therapy inappropriate
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or think they may be pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description F&P Toffee mask F&P Toffee mask Participants will be placed on this arm for a total of 14 ± 5 days from Visit two. Participants will be using the trial full-face mask during this treatment arm.
- Primary Outcome Measures
Name Time Method Trial Mask Comfort 14 ± 5 days In-Home Comfort comparison of trial mask compared to their usual mask. Determined from custom questionnaires - Subjective
Trial Mask Performance - Objective 14 ± 5 days In-Home Performance data recorded from the PAP device comparing leak at baseline compared to with trial mask - Objective
Trial Mask Performance - Subjective 14 ± 5 days In-Home Seal leak in comparison to their usual mask. Determine from questionnaires - Subjective
Trial Mask Usability During Visit Two - 20 minutes Whether the patient got the correct orientation and positioning of mask without help. Usability interview - Subjective
Trial Mask Ease-of-Use 14 ± 5 days In-Home Usability of trial mask compared to usual mask. Determined from questionnaires - Subjective
- Secondary Outcome Measures
Name Time Method Mask Leak Data 14 ± 5 days In-Home Leak data recorded from PAP device - Objective
Seal Size Determination 1 day-time appointment (1 hour) during Visit Two Did the sizing tool designed for the trial mask correctly predict which size was best suited for the participant.
Efficacy Data 14 ± 5 days In-Home AHI data recorded from PAP device comparing trial mask use to baseline measurements - Objective
Trial Locations
- Locations (1)
California Sleep Solutions
🇺🇸Roseville, California, United States