The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort
|ClinicalTrials.gov Identifier: NCT02851628|
Recruitment Status : Completed
First Posted : August 1, 2016
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sleep Disordered Breathing Obstructive Sleep Apnea||Device: Alternative sizing model based trial mask Device: Prototype Full Face Mask||Not Applicable|
The investigation is a prospective non-blinded and semi-randomized investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the Prototype Full Face Mask (PFFM) mask. A cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by Fisher & Paykel Healthcare in Auckland New Zealand, Waikato DHB in Hamilton New Zealand, Hawkes Bay DHB in Hastings New Zealand and WellSleep Centre in Wellington New Zealand.
The study will involve baseline (visit one) gathering the participants' prescribed PAP therapy pressure and their usual mask (to have up-to-date records). The next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the Prototype Full Face Mask (PFFM) mask or the alternative sizing based trial mask. At visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. At visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full-face Masks in the Treatment of OSA in Terms of Performance and Comfort|
|Actual Study Start Date :||September 11, 2017|
|Actual Primary Completion Date :||November 3, 2017|
|Actual Study Completion Date :||December 20, 2017|
Experimental: Alternative sizing model trial mask
In this arm participants who are randomized to the alternative sizing model based mask will be given the alternative sizing model based mask to use in home for the duration of this arm.
Device: Alternative sizing model based trial mask
A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.
Active Comparator: Prototype Full Face Mask (PFFM)
In this arm, participants who are randomized to the PFFM will be given the PFFM to use in-home for the duration of this arm.
Device: Prototype Full Face Mask
A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.
- Seal Comfort [ Time Frame: Up to 3 weeks in-home ]Obtained from subjective questionnaire
- Subjective Seal Leak [ Time Frame: Up to 3 weeks in-home ]Obtained from subjective questionnaire
- Objective Seal Leak [ Time Frame: Up to 3 weeks in-home ]Measured by device data
- Objective correct mask selection [ Time Frame: Up to 3 weeks in-home ]Measured by device leak data
- Subjective correct mask selection [ Time Frame: Up to 3 weeks in-home ]Measured by subjective questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851628
|Hastings Memorial Hospital|
|Hastings, Hawkes Bay, New Zealand, 1420|
|Waikato Hospital (Waikato DHB)|
|Hamilton, Waikato, New Zealand, 3204|
|Fisher & Paykel Healthcare|
|Auckland, New Zealand, 2013|
|Wellington, New Zealand, 6035|
|Principal Investigator:||Kayan Gonda, BSc||Sponsor Employee|