NCT03329352

Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The 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.

Detailed description

The investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA participants who currently use a full-face mask will be recruited. The study will involve a baseline (Visit 1) data gathering with the participant's PAP therapy and their usual mask. This will be followed by the participants being fitted with the trial full-face mask by a sleep technician for use in-home (Visit 2). The participant then will come in to return the mask (Visit 3) and give feedback on their experience using the mask in home in the form of a structured interview during Visit 3. If the participants prefer the trial full-face mask they will be asked if they would like to continue using the trial mask for a further six months in home. There will be a follow up phone call gain feedback or address any issues at months 2 and 4 of the six month extension period. At the end of the six month extension period, the participants will return the trial full-face mask to NTLSC and answer a few questions around their feedback on the mask after using it for six months. The mask and CPAP (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of Obstructive Sleep Apnea. Neither the investigators nor the participants will be blinded to the study. Data from initial 2 week trial is reported here.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	F&P Full-Face Mask	The F\&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.

Timeline

• Start date: 2017-11-03
• Primary completion: 2018-07-31
• Completion: 2018-07-31
• First posted: 2017-11-06
• Last updated: 2021-11-10
• Results posted: 2021-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study