The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

Fisher and Paykel Healthcare33 enrolled

Overview

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

A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sleep Disordered Breathing Obstructive Sleep Apnea

Interventions

F&P InterfaceDEVICE

F\&P Interface 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 written consent * AHI ≥ 5 on diagnostic night * Either prescribed APAP, CPAP or Bi-level PAP for OSA Exclusion Criteria: * Inability to give written consent * Anatomical or physiological conditions making PAP therapy inappropriate * Commercial drivers who are investigated by New Zealand Transport Agency (NZTA) * Current diagnosis of respiratory disease or CO2 retention * Pregnant or may think they are pregnant.

Locations (3)

Hawkes Bay Fallen Soldiers' Memorial Hospital

Hastings, Hawkes Bay, New Zealand

Fisher & Paykel Healthcare

Auckland, New Zealand

Well Sleep

Wellington, New Zealand

Outcomes

Primary Outcomes

Trial Mask usability

Questionnaire on ease-of-use (very easy to very difficult) Subjective

Time frame: 14 ± 4 days in home

Trial mask Performance

Questionnaire on performance (very good to very poor)- Subjective

Time frame: 14 ± 4 days in home

Secondary Outcomes

Trial mask Reliability

Questionnaire on reliability - Subjective

Time frame: 5 months and 2 weeks in home

Trial mask performance measured in L/min

Objective leak data from PAP device

Time frame: 14 ± 4 days in home

Data from ClinicalTrials.gov

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