A Development Study to Evaluate a 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

NCT03124069

Run by

Fisher and Paykel Healthcare

People needed

37

Starts

2017-04-24

Expected to finish

2017-09-30

Last updated by the study team

2021-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AHI ≥ 5 from diagnostic PSG night
• Aged 22 and over (FDA defined as adult)
• Either prescribed APAP, CPAP or Bi-Level PAP for OSA
• Existing nasal or nasal pillows mask users (preferable 70%:30% split)
• Fluent in spoken and written English

You may not qualify if…

• Inability to give informed consent
• Patient intolerant to CPAP therapy
• Anatomical or physiological conditions making PAP therapy inappropriate
• Current diagnosis of respiratory disease or CO2 retention
• Pregnant or think they may be pregnant

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.