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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing
• Interventions: Device: F&P Interface

• Registration Number: NCT03725839
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

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

• Study First Submitted: 2018-10-28
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Study Start: 2018-11-05
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hawkes Bay Fallen Soldiers' Memorial Hospital; 🇳🇿 Hastings, Hawkes Bay, New Zealand

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand

Well Sleep; 🇳🇿 Wellington, New Zealand