The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Not Applicable

Completed

• Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea
• Interventions: Device: F&P Deimos Nasal Pillows Mask

• Registration Number: NCT02894242
• 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 mask.

Detailed Description

A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-09
• Primary Completion: 2017-01
• Study Completion: 2017-03
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-02
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Adult (18+ years of age)
• Able to give consent
• Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
• Prescribed PAP for OSA
• Existing nasal pillows user

Exclusion Criteria

• Inability to give consent
• Patients who are in a coma or a decreased level of consciousness
• Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency
• Current diagnosis of carbon dioxide (CO2) retention
• Pregnant or may think they are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
F&P Deimos Nasal Pillows Mask	F&P Deimos Nasal Pillows Mask	Participants to use nasal pillows mask in-home for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Ease of use	2 weeks in home	Subjective questionnaire
Acceptability	2 weeks in home	Subjective questionnaire

Secondary Outcome Measures

Name	Time	Method
Objective leak data	2 weeks in home	Obtained from participants' device

Trial Locations

Locations (2)

Fisher and Paykel Healthcare; 🇳🇿 Auckland, New Zealand

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