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

Not Applicable

Completed

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

• Registration Number: NCT03413098
• 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 mask amongst Obstructive Sleep Apnea (OSA) patients.

Detailed Description

Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F\&P trial nasal mask for use in-home.

The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two.

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 patients within 1 week of the beginning of the study.

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2018-02-12
• Primary Completion: 2018-03-09
• Study Completion: 2018-03-09
• Last Update Submitted: 2018-03-20
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Arm && Interventions

Group	Intervention	Description
Trial nasal Continuous Positive Airway Pressure (CPAP) mask	Nasal CPAP mask	Trial nasal CPAP mask

Primary Outcome Measures

Name	Time	Method
Ease of use	2 weeks	Subjective Questionnaire
Acceptability	2 weeks	Subjective Questionnaire

Secondary Outcome Measures

Name	Time	Method
Objective leak data	2 weeks	Data obtained from participant's device - Objective

Trial Locations

Locations (2)

WellSleep; 🇳🇿 Wellington, New Zealand

Hastings Memorial Hospital; 🇳🇿 Hastings, New Zealand