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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02297789
• Other study ID #: CIA-152
• Status: Completed
• Phase: N/A
• First received: November 19, 2014
• Last updated: July 22, 2015
• Start date: November 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Investigative Full Face Mask with Headgear

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare Ltd.	Auckland	East Tamaki

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mask is comfortable and is effective for the participant during in-home use	Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data.	1 week for each mask prototype in-home	No
Secondary	Acceptability of the Full Face mask prototypes	Preference for one of the Full Face Mask prototypes design through a custom questionnaire and a daily participant feedback log	1 week for each mask prototype in-home	No