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: | 3/28/2019 |
| Start Date: | May 30, 2017 |
| End Date: | June 23, 2017 |
The Evaluation of a Full Face and Nasal Mask for the Treatment of Obstructive Sleep Apnea
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
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
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.
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.
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.
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