The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing

• Registration Number: NCT03156413
• 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 maximum of 12 OSA participants who currently use a nasal mask will be recruited for the trial. Participant will be on the trial for 1 night (in-lab)

Study Timeline

• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Study Start: 2017-05-29
• Primary Completion: 2017-06-05
• Study Completion: 2017-06-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 mask 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

Primary Outcome Measures

Name	Time	Method
Ease of use	1 night	Subjective questionnaire
Acceptability	1 night	Subjective questionnaire

Secondary Outcome Measures

Name	Time	Method
Objective leak data	1 night	Data obtained from participant's device - Objective

Trial Locations

Locations (1)

Fisher and Paykel Healthcare; 🇳🇿 Auckland, New Zealand