The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
Status
Conditions
Treatments
Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
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 oronasal and nasal 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
57 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal