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

Fisher and Paykel Healthcare39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Trial Nasal MaskDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Waikato District Health Board

Hamilton, New Zealand

Hawke's Bay District Health Board

Hastings, New Zealand

Outcomes

Primary Outcomes

Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire

Time frame: 2 weeks in home

Secondary Outcomes

Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.

the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"

Time frame: 2 weeks in home

Objective leak data through the Positive Airway Pressure therapy device

Evaluating the leak of the trial Nasal mask

Time frame: 2 weeks in home

Treatment efficacy through the Positive Airway Pressure therapy device

Evaluating the number of apnea/hypopnea per hour

Time frame: 2 weeks in home

Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.

the participant would either choose the trial Nasal mask or their usual mask as their primary mask

Time frame: 2 weeks in home

Data from ClinicalTrials.gov

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