The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea

Fisher and Paykel Healthcare12 enrolled

Overview

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

A maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Disordered Breathing Obstructive Sleep Apnea

Interventions

F&P nasal maskDEVICE

Investigative Nasal Mask to be used for OSA therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult (18+ years of age) * Able to give consent * Apnea hypopnea Index (AHI)≥ 5 on diagnostic night * Prescribed PAP for OSA * Existing nasal 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 automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure) * Commercial drivers who are investigated by New Zealand Transport Agency * Current diagnosis of carbon dioxide (CO2) retention * Pregnant or may think they are pregnant

Locations (1)

Fisher and Paykel Healthcare

Auckland, New Zealand

Outcomes

Primary Outcomes

Ease of use

Subjective questionnaire

Time frame: 1 night

Acceptability

Subjective questionnaire

Time frame: 1 night

Secondary Outcomes

Objective leak data

Data obtained from participant's device - Objective

Time frame: 1 night

Data from ClinicalTrials.gov

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