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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sleep Disordered Breathing Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm

F\&P Interface will be used by OSA participants in-home for 2 weeks.

Group Type EXPERIMENTAL

F&P Interface

Intervention Type DEVICE

F\&P Interface to be used for OSA therapy

Interventions

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F&P Interface

F\&P Interface to be used for OSA therapy

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No