Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Investigative Full Face Mask with Headgear

Study type: Interventional

Funder types: Industry

Identifiers

NCT02297789

CIA-152

Details and patient eligibility

About

Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.

The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• AHI ≥ 5 from the diagnostic night
• ≥ 18 years of age
• Either prescribed APAP or CPAP or Bi level for OSA
• Existing full face users

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Headgear 1

Experimental group

Description:

Full Face Mask with Headgear 1

Treatment:

Device: Investigative Full Face Mask with Headgear

Headgear 2

Experimental group

Description:

Full Face Mask with Headgear 2

Treatment:

Device: Investigative Full Face Mask with Headgear