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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Nasal Pillows CPAP mask

• Registration Number: NCT03605485
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.

Detailed Description

Visit 1 will involve the participants consented in to the trial. Participants will be fitted with the F\&P trial nasal pillows mask for use in-lab.

The participant will then return the mask and have a interview, this ensures the maximum time participants will be exposed to the trial mask in lab will be in 1 night.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all participants within 1 week of the beginning of the study.

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-22
• Study First Submitted QC: 2018-07-22
• Study First Posted: 2018-07-30
• Study Start: 2018-08-07
• Primary Completion: 2018-08-10
• Study Completion: 2018-08-10
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 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
Trial Continuous Positive Airway Pressure (CPAP) mask	Nasal Pillows CPAP mask	Trial nasal pillows CPAP mask

Primary Outcome Measures

Name	Time	Method
Acceptability	1 night	Subjective Questionnaire
Ease of use	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 & Paykel Helathcare; 🇳🇿 Auckland, New Zealand