The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Fisher and Paykel Healthcare18 enrolled

Overview

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

A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week. An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Disordered Breathing Obstructive Sleep Apnea

Interventions

F&P Mask SealDEVICE

Investigative Mask Seal to be used for OSA therapy

F&P MaskDEVICE

Investigative 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 oro-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 & Paykel Healthcare

Auckland, New Zealand

Outcomes

Primary Outcomes

Ease of use

Subjective questionnaire

Time frame: 1 week in home

Acceptability

Subjective questionnaire

Time frame: 1 week in home

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: 1 week in home

Data from ClinicalTrials.gov

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