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

Fisher & Paykel Healthcare

Status: Completed

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Treatments: Device: F&P Interface

Study type: Interventional

Funder types: Industry

Identifiers

NCT03725839

CIA-249

Details and patient eligibility

About

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

Full description

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Arm

Experimental group

Description:

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

Treatment:

Device: F&P Interface