The Evaluation of the Toffee Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Ohio Sleep Medical Institute (OSMI)

Key facts

Study ID

NCT03242148

Run by

Fisher and Paykel Healthcare

People needed

38

Starts

2017-09-16

Expected to finish

2017-11-03

Last updated by the study team

2021-09-22

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 nasal pillows 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

• Ohio Sleep Medicine Institute — Dublin, Ohio, United States

Full record on ClinicalTrials.gov

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