The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Completed

Conditions studied: Obstructive Sleep Apnea

In brief

The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

Key facts

Study ID

NCT03230877

Run by

Fisher and Paykel Healthcare

People needed

38

Starts

2017-09-02

Expected to finish

2017-11-30

Last updated by the study team

2022-09-08

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 F\&P full face mask user

You may not qualify if…

• 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.

Where it is running

• Clinical Trials of Florida — Miami, Florida, United States

Full record on ClinicalTrials.gov

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