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

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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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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