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

Fisher & Paykel Healthcare

Status: Completed

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Treatments: Device: Prototype Full Face Mask; Device: Alternative sizing model based trial mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT02851628

CIA-194

Details and patient eligibility

About

The investigation is a prospective non-blinded and semi-randomized clinical 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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult (18+ years of age)
• Able to give consent
• Apnea Hypopnea Index (AHI) ≥ 5 on diagnostic night
• Prescribed a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
• Existing nasal or full face mask user.

Exclusion criteria

• Inability to give consent
• Patients who are in a coma or a decreased level of consciousness.
• Anatomical or physiological conditions making APAP therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
• Current diagnosis of CO2 retention
• Pregnant or may think they are pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Alternative sizing model trial mask

Experimental group

Description:

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.

Treatment:

Device: Alternative sizing model based trial mask

Prototype Full Face Mask (PFFM)

Active Comparator group

Description:

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.

Treatment:

Device: Prototype Full Face Mask