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OpenTrials
Completed

NCT Number: NCT03725839

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

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

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Key information

Conditions

Sleep Disordered Breathing Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hawkes Bay Fallen Soldiers' Memorial Hospital, Hastings, Hawkes Bay, New Zealand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

F&P Interface

Device

F&P Interface to be used for OSA therapy

Primary outcomes

  1. Trial Mask usability

    Time frame: 14 ± 4 days in home

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

  2. Trial mask Performance

    Time frame: 14 ± 4 days in home

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

Secondary outcomes

  1. Trial mask Reliability

    Time frame: 5 months and 2 weeks in home

    Questionnaire on reliability - Subjective

  2. Trial mask performance measured in L/min

    Time frame: 14 ± 4 days in home

    Objective leak data from PAP device

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2018
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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