The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Device: F&P Seal Improvement Project
- Registration Number
- NCT03142438
- Lead Sponsor
- Fisher and Paykel Healthcare
- Brief Summary
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial full face and nasal mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 70 OSA patients will be recruited from the North Texas Lung and Sleep Clinic (NTLSC) database
- Detailed Description
Visit 1 will involve the participants being fitted with the F\&P trial full face or nasal mask for use in-home.
The participant will then come in to return the mask (Visit Two) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit one.
The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within three weeks of the beginning of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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 oronasal and nasal mask user
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description F&P Seal Improvement Project F&P Seal Improvement Project participants will be placed on this arm for a total of 14 +- 4 days from visit 1. participants will be using the trial mask during this treatment arm
- Primary Outcome Measures
Name Time Method Number of Participants Subjective Usability Reporting 14 ± 4 days in-Home Usability reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Number or Participants Comparative Subjective Reported Comfort 14 ± 4 days in-Home Comfort reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea compared to usual
- Secondary Outcome Measures
Name Time Method Objective Performance Reporting 14 ± 4 days in-Home Objective Apnea-Hypopnea Index (AHI) data recorded from the positive airway pressure (PAP) device to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Number of Participants Reported Mask Acceptability 14 ± 4 days in-Home Acceptability reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Number of Participants Subjective Comfort Reporting 14 ± 4 days in-Home Comfort reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Number or Participants Subjective Reporting of Seal Performance 14 ± 4 days in-Home Seal performance reported from participants questionnaires to evaluate the use of the F\&P mask for treatment of Obstructive Sleep Apnea
Trial Locations
- Locations (1)
North texas Lung and Sleep Clinic
🇺🇸Fort Worth, Texas, United States