Respiratory Emissions in Healthy Participants

January 8, 2025 updated by: Fisher and Paykel Healthcare
This is an randomised cross over trial in healthy participants measuring respiratory emissions during different respiratory activities.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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 and 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

Description

Inclusion Criteria:

  • Adults, over the age of 18 and able to give informed consent
  • Symptom free from any respiratory illness in the last 48 hours

Exclusion Criteria:

  • Pregnant (where the participant feels that their pregnancy will make participation uncomfortable)
  • Inability to give consent
  • Current respiratory disease. Participants with well controlled asthma will be included (defined as asthma that the participant self-rates their asthma as being under control and that does not limit exercise, work)

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Respiratory Activity 1
Behavioral: Exertional respiratory activities
participants will perform a series of exertional respiratory activities
Experimental: Respiratory Activity 2
Behavioral: Exertional respiratory activities
participants will perform a series of exertional respiratory activities
Experimental: Respiratory Activity 3
Behavioral: Exertional respiratory activities
participants will perform a series of exertional respiratory activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of total number of respiratory particles emitted during respiratory activities in the range of 0.3 to 25 microns
Time Frame: Emission of particles will be collected and analysed for 2 minutes during each experimental condition
Particles emitted will be counted using two different optical particle counters
Emission of particles will be collected and analysed for 2 minutes during each experimental condition

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)

March 8, 2022

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

January 9, 2025

Study Registration Dates

First Submitted

December 8, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • CIA-292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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