An Investigation to Test a Prototype Nasal Mask in the Home Setting

January 22, 2019 updated by: Fisher and Paykel Healthcare
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand, 2013
        • Fisher & Paykel Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • OSA Mask Users
  • 18+ years of age
  • Ability to give informed consent

Exclusion Criteria:

  • Inability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm
Experimental: User Instructions of a Novel Nasal Mask Participants to interpret user instructions in a one hour daytime visit.
Device: User Instructions of novel nasal mask
User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mask User Instructions Interpretation
Time Frame: 3 days
Determined as interpreted by participants from open-ended questions (Open ended questionnaire, very easy - very difficult)- Subjective
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2018

Primary Completion (Actual)

October 18, 2018

Study Completion (Actual)

October 19, 2018

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA-240

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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