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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Trial Nasal Mask
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Waikato District Health Board
  • Hawke's Bay District Health Board

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trial Nasal Mask

Arm Description

The participant will use the Saturn nasal mask for 2 weeks in home

Outcomes

Primary Outcome Measures

Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire

Secondary Outcome Measures

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.
the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"
Objective leak data through the Positive Airway Pressure therapy device
Evaluating the leak of the trial Nasal mask
Treatment efficacy through the Positive Airway Pressure therapy device
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.
the participant would either choose the trial Nasal mask or their usual mask as their primary mask

Full Information

First Posted
September 1, 2015
Last Updated
July 31, 2019
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02541214
Brief Title
Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trial Nasal Mask
Arm Type
Experimental
Arm Description
The participant will use the Saturn nasal mask for 2 weeks in home
Intervention Type
Device
Intervention Name(s)
Trial Nasal Mask
Primary Outcome Measure Information:
Title
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
Time Frame
2 weeks in home
Secondary Outcome Measure Information:
Title
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.
Description
the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"
Time Frame
2 weeks in home
Title
Objective leak data through the Positive Airway Pressure therapy device
Description
Evaluating the leak of the trial Nasal mask
Time Frame
2 weeks in home
Title
Treatment efficacy through the Positive Airway Pressure therapy device
Description
Evaluating the number of apnea/hypopnea per hour
Time Frame
2 weeks in home
Title
Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.
Description
the participant would either choose the trial Nasal mask or their usual mask as their primary mask
Time Frame
2 weeks in home

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Waikato District Health Board
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Facility Name
Hawke's Bay District Health Board
City
Hastings
ZIP/Postal Code
9014
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

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

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