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

Not Applicable

Completed

• Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea
• Interventions: Device: Trial Nasal mask

• Registration Number: NCT02730273
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).

Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2016-03
• Study First Submitted: 2016-03-13
• Study First Submitted QC: 2016-03-31
• Study Completion: 2016-04
• Study First Posted: 2016-04-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-13
• Last Update Posted: 2017-07-17

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 a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
• Existing nasal or nasal pillow 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 APAP therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
• Current diagnosis of 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 Mask	Trial Nasal mask	Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography.

Primary Outcome Measures

Name	Time	Method
Comfort	Up to 1 week in-home	Subjective Questionnaire
Draft	Up to 1 week in-home	Subjective Questionnaire
Objective leak data (L/min)	1 night	Obtained from the overnight polysomnography
Subjective measurement of leak	Up to 1 week in-home	Subjective Questionnaire
Stability	Up to 1 week in-home	Subjective Questionnaire
Noise	Up to 1 week in-home	Subjective Questionnaire

Secondary Outcome Measures

Name	Time	Method
Preference of the mask	Up to 1 week in-home	Subjective Questionnaire

Trial Locations

Locations (1)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand