NCT05169723

Brief Summary

This is an randomised cross over trial in healthy participants measuring respiratory emissions during different respiratory activities.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2022

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 8, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

12 months

First QC Date

December 8, 2021

Last Update Submit

January 8, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Count of total number of respiratory particles emitted during respiratory activities in the range of 0.3 to 25 microns

    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

Study Arms (3)

Respiratory Activity 1

EXPERIMENTAL
Behavioral: Exertional respiratory activities

Respiratory Activity 2

EXPERIMENTAL
Behavioral: Exertional respiratory activities

Respiratory Activity 3

EXPERIMENTAL
Behavioral: Exertional respiratory activities

Interventions

Exertional respiratory activitiesBEHAVIORAL

participants will perform a series of exertional respiratory activities

Respiratory Activity 1Respiratory Activity 2Respiratory Activity 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisher and Paykel Healthcare

Auckland, 2013, New Zealand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 27, 2021

Study Start

March 8, 2022

Primary Completion

March 1, 2023

Study Completion

January 9, 2025

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)