The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Key facts

Study ID

NCT04011826

Run by

Fisher and Paykel Healthcare

People needed

45

Starts

2019-08-05

Expected to finish

2020-08-30

Last updated by the study team

2021-12-01

Who can join

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

You may qualify if…

• Diagnosis of OSA by Physician
• ≥ 22 years of age
• ≥ 66 lbs
• Prescribed PAP or BPAP therapy for OSA
• Existing nasal, sub-nasal and pillows mask users
• Fluent in written and spoken English

You may not qualify if…

• Inability to give informed consent
• Pregnant or think they may be pregnant
• PAP Intolerant
• Anatomical or Physiological Conditions that make PAP inappropriate
• IPAP pressure of ≤25cmH20.
• PAP/BPAP therapy device without data recording capabilities
• Using a PAP/BPAP therapy device for the delivery any medication with the exception of oxygen

Where it is running

• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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