Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Trial Nasal Mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT02541214

CIA-171

Details and patient eligibility

About

Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.

This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.

Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18+
• Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
• Existing nasal or nasal pillows user
• Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Trial Nasal Mask

Experimental group

Description:

The participant will use the Saturn nasal mask for 2 weeks in home

Treatment:

Device: Trial Nasal Mask