Back to resultsThe Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Primary Purpose
Sleep Disordered Breathing, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
F&P Deimos Nasal Pillows Mask
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disordered Breathing
Eligibility Criteria
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 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
Sites / Locations
- Fisher and Paykel Healthcare
- Hawkes Bay Fallen Soldiers' Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
F&P Deimos Nasal Pillows Mask
Arm Description
Participants to use nasal pillows mask in-home for 2 weeks.
Outcomes
Primary Outcome Measures
Ease of use
Subjective questionnaire
Acceptability
Subjective questionnaire
Secondary Outcome Measures
Objective leak data
Obtained from participants' device
Full Information
NCT ID
NCT02894242
First Posted
September 5, 2016
Last Updated
April 2, 2017
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02894242
Brief Title
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Official Title
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
Detailed Description
A minimum of 20 OSA participants who currently use a nasal pillows mask will be recruited for the trial. Participant will be on the trial for three weeks - first week will be a collection of Positive Airway Pressure (PAP) baseline data on the participant's usual mask. The participant will then use the trial mask in-home for 2 weeks. There is also an option of a two month extension if the participant wish to continue on the trial mask.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing, 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
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
F&P Deimos Nasal Pillows Mask
Arm Type
Experimental
Arm Description
Participants to use nasal pillows mask in-home for 2 weeks.
Intervention Type
Device
Intervention Name(s)
F&P Deimos Nasal Pillows Mask
Other Intervention Name(s)
Deimos Mask
Intervention Description
Investigative Nasal Pillows Mask to be used for OSA therapy
Primary Outcome Measure Information:
Title
Ease of use
Description
Subjective questionnaire
Time Frame
2 weeks in home
Title
Acceptability
Description
Subjective questionnaire
Time Frame
2 weeks in home
Secondary Outcome Measure Information:
Title
Objective leak data
Description
Obtained from participants' device
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:
Adult (18+ years of age)
Able to give consent
Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
Prescribed PAP for OSA
Existing nasal pillows 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Gunson, Bsc PgDip
Organizational Affiliation
Sponsor Employee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher and Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand
Facility Name
Hawkes Bay Fallen Soldiers' Memorial Hospital
City
Hastings
ZIP/Postal Code
4120
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
For product development purposes only. Data will be deidentified.
Learn more about this trial
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
We'll reach out to this number within 24 hrs