The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Fisher and Paykel Healthcare22 enrolled

Overview

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

A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Disordered Breathing Obstructive Sleep Apnea

Interventions

F&P Deimos Nasal Pillows MaskDEVICE

Investigative Nasal Pillows 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 pillows 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 (2)

Fisher and Paykel Healthcare

Auckland, New Zealand

Hawkes Bay Fallen Soldiers' Memorial Hospital

Hastings, New Zealand

Outcomes

Primary Outcomes

Ease of use

Subjective questionnaire

Time frame: 2 weeks in home

Acceptability

Subjective questionnaire

Time frame: 2 weeks in home

Secondary Outcomes

Objective leak data

Obtained from participants' device

Time frame: 2 weeks in home

Data from ClinicalTrials.gov

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