Back to resultsAn Investigation to Test a Prototype Nasal Mask in the Home Setting
Primary Purpose
Sleep Disordered Breathing, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
User Instructions of novel nasal mask
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disordered Breathing
Eligibility Criteria
Inclusion Criteria:
- OSA Mask Users
- 18+ years of age
- Ability to give informed consent
Exclusion Criteria:
- Inability to give informed consent
Sites / Locations
- Fisher & Paykel Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm
Arm Description
Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.
Outcomes
Primary Outcome Measures
Mask User Instructions Interpretation
Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective
Secondary Outcome Measures
Full Information
NCT ID
NCT03752580
First Posted
November 20, 2018
Last Updated
January 22, 2019
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT03752580
Brief Title
An Investigation to Test a Prototype Nasal Mask in the Home Setting
Official Title
An Investigation to Test a Prototype Nasal Mask in the Home Setting
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
October 19, 2018 (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 a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. A minimum of 15 participants will participate in this trial.
Detailed Description
This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants. The clinical investigation will be conducted in New Zealand and participants will interact with the user instructions in a one hour daytime visit. This investigation is designed to evaluate the interpretation by participants of the user instructions. A total number of 20 participants, diagnosed with OSA will be recruited for the trial. The participants will be recruited from the Fisher and Paykel Healthcare Database of subjects (Ethics reference 18/NTA/62).
Fisher and Paykel Healthcare will act as the investigator and sponsor for this investigation. This study will be conducted in accordance with ICH/GCP Guidelines. No deviation from protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor (Bhavi Ogra) as soon as possible.
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
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm
Arm Type
Experimental
Arm Description
Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.
Intervention Type
Device
Intervention Name(s)
User Instructions of novel nasal mask
Intervention Description
User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).
Primary Outcome Measure Information:
Title
Mask User Instructions Interpretation
Description
Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
OSA Mask Users
18+ years of age
Ability to give informed consent
Exclusion Criteria:
Inability to give informed consent
Facility Information:
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
An Investigation to Test a Prototype Nasal Mask in the Home Setting
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