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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing
• Intervention / Treatment: Device: F&P Interface

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 2013
    • Fisher & Paykel Healthcare
  • Wellington, New Zealand, 6035
    • Well Sleep
  • Hawkes Bay
    • Hastings, Hawkes Bay, New Zealand, 4120
      • Hawkes Bay Fallen Soldiers' Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm; F&P Interface will be used by OSA participants in-home for 2 weeks.	Device: F&P Interface; F&P Interface to be used for OSA therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial Mask usability	Questionnaire on ease-of-use (very easy to very difficult) Subjective	14 ± 4 days in home
Trial mask Performance	Questionnaire on performance (very good to very poor)- Subjective	14 ± 4 days in home

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trial mask Reliability	Questionnaire on reliability - Subjective	5 months and 2 weeks in home
Trial mask performance measured in L/min	Objective leak data from PAP device	14 ± 4 days in home

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Bhavi Ogra, Clinical Manager

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: October 28, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: CIA-249

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No