The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)

Not Applicable

Completed

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

• Registration Number: NCT03092921
• 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 seal/mask.

Detailed Description

A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.

An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Study Timeline

• Study First Submitted: 2017-03-22
• Study First Submitted QC: 2017-03-22
• Study Start: 2017-03-27
• Study First Posted: 2017-03-28
• Status Verified: 2017-08
• Primary Completion: 2017-08-03
• Study Completion: 2017-08-03
• Last Update Submitted: 2017-08-06
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
F&P Mask	F&P Mask	Participants to use trial mask in-home for 2 weeks
F&P Mask Seal	F&P Mask Seal	Participants to use trial seal in-home for 1 week

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Objective leak data	1 week in home	Obtained from participants' device

Trial Locations

Locations (1)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand