NCT03463096

Brief Summary

This is a study of advanced lung physiology in altered gravitational conditions, consisting of respiratory measurements in healthy volunteers during high G acceleration on a long-arm human centrifuge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 20, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
Last Updated

September 25, 2018

Status Verified

February 1, 2018

Enrollment Period

5 months

First QC Date

February 28, 2018

Last Update Submit

September 24, 2018

Conditions

Respiratory Physiology

Keywords

respiratoryphysiologygravity

Outcome Measures

Primary Outcomes (1)

  • Lung inhomogeneity index

    The lung inhomogeneity index is the standard deviation for the natural logarithm of the standardised lung compliance, equivalent to the standard deviation for the natural logarithm of the ratio between fractional lung compliance and fractional alveolar volume of the lung units. It is determined using the respiratory data obtained by molecular flow sensing using the laser gas analyser.

    Determined over a 15-minute multi-breath washout at 3 G on the centrifuge

Study Arms (1)

Centrifuge study

EXPERIMENTAL

High G acceleration on a long-arm human centrifuge

Other: High G acceleration on a long-arm human centrifuge

Interventions

High G acceleration on a long-arm human centrifugeOTHER

Gx (chest-to-back) and Gz (head-to-toe)

Centrifuge study

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteer who has provided informed consent

You may not qualify if:

  • any significant medical problem, as documented extensively in the study ethics documentation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Human and Aerospace Physiological Sciences

London, SE11UL, United Kingdom

Location

Study Officials

  • Thomas G Smith

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 13, 2018

Study Start

February 20, 2018

Primary Completion

July 31, 2018

Study Completion

July 31, 2018

Last Updated

September 25, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)