The Evaluation of an Interface 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 Interface
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 written consent
- AHI ≥ 5 on diagnostic night
- Either prescribed APAP, CPAP or Bi-level PAP for OSA
Exclusion Criteria:
- Inability to give written consent
- Anatomical or physiological conditions making PAP therapy inappropriate
- Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
- Current diagnosis of respiratory disease or CO2 retention
- Pregnant or may think they are pregnant.
Sites / Locations
- Hawkes Bay Fallen Soldiers' Memorial Hospital
- Fisher & Paykel Healthcare
- Well Sleep
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm
Arm Description
F&P Interface will be used by OSA participants in-home for 2 weeks.
Outcomes
Primary Outcome Measures
Trial Mask usability
Questionnaire on ease-of-use (very easy to very difficult) Subjective
Trial mask Performance
Questionnaire on performance (very good to very poor)- Subjective
Secondary Outcome Measures
Trial mask Reliability
Questionnaire on reliability - Subjective
Trial mask performance measured in L/min
Objective leak data from PAP device
Full Information
NCT ID
NCT03725839
First Posted
October 28, 2018
Last Updated
February 26, 2020
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03725839
Brief Title
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
Official Title
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (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 Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
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 interface.
Detailed Description
A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.
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
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm
Arm Type
Experimental
Arm Description
F&P Interface will be used by OSA participants in-home for 2 weeks.
Intervention Type
Device
Intervention Name(s)
F&P Interface
Intervention Description
F&P Interface to be used for OSA therapy
Primary Outcome Measure Information:
Title
Trial Mask usability
Description
Questionnaire on ease-of-use (very easy to very difficult) Subjective
Time Frame
14 ± 4 days in home
Title
Trial mask Performance
Description
Questionnaire on performance (very good to very poor)- Subjective
Time Frame
14 ± 4 days in home
Secondary Outcome Measure Information:
Title
Trial mask Reliability
Description
Questionnaire on reliability - Subjective
Time Frame
5 months and 2 weeks in home
Title
Trial mask performance measured in L/min
Description
Objective leak data from PAP device
Time Frame
14 ± 4 days 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 written consent
AHI ≥ 5 on diagnostic night
Either prescribed APAP, CPAP or Bi-level PAP for OSA
Exclusion Criteria:
Inability to give written consent
Anatomical or physiological conditions making PAP therapy inappropriate
Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
Current diagnosis of respiratory disease or CO2 retention
Pregnant or may think they are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhavi Ogra
Organizational Affiliation
Clinical Manager
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hawkes Bay Fallen Soldiers' Memorial Hospital
City
Hastings
State/Province
Hawkes Bay
ZIP/Postal Code
4120
Country
New Zealand
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand
Facility Name
Well Sleep
City
Wellington
ZIP/Postal Code
6035
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)
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