Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Trial Nasal Mask

• Registration Number: NCT02541214
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.

This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.

Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-31
• Last Update Posted: 2019-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Aged 18+
• Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
• Existing nasal or nasal pillows user
• Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))

Exclusion Criteria

• Inability to give informed consent
• Pregnant or think they may be pregnant
• Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
• Patients who are in a coma or decreased level of consciousness
• Current diagnosis of CO2 retention
• Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trial Nasal Mask	Trial Nasal Mask	The participant will use the Saturn nasal mask for 2 weeks in home

Primary Outcome Measures

Name	Time	Method
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire	2 weeks in home

Secondary Outcome Measures

Name	Time	Method
Treatment efficacy through the Positive Airway Pressure therapy device	2 weeks in home	Evaluating the number of apnea/hypopnea per hour
Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.	2 weeks in home	the participant would either choose the trial Nasal mask or their usual mask as their primary mask
Objective leak data through the Positive Airway Pressure therapy device	2 weeks in home	Evaluating the leak of the trial Nasal mask
Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.	2 weeks in home	the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"

Trial Locations

Locations (2)

Waikato District Health Board; 🇳🇿 Hamilton, New Zealand

Hawke's Bay District Health Board; 🇳🇿 Hastings, New Zealand