The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 4/6/2019 |
| Start Date: | November 26, 2018 |
| End Date: | December 13, 2018 |
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 mask amongst
Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the
Pulmonary Disease Specialists Research database
designed to evaluate the performance, comfort and ease of use with the F&P trial mask amongst
Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the
Pulmonary Disease Specialists Research database
Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the
participants being fitted with the F&P trial mask for use in home. The participant will then
come in to return the mask (Visit Three) 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
two. 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 2 weeks of the beginning of the study.
participants being fitted with the F&P trial mask for use in home. The participant will then
come in to return the mask (Visit Three) 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
two. 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 2 weeks of the beginning of the study.
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 OSA 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.
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