Effects of Low Concentrations of Nitrous Oxide
1 other identifier
interventional
16
1 country
1
Brief Summary
The aim of the study is to test the effects of low concentrations of nitrous oxide on cognitive functions and reaction time in human.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2019
1 active site
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
April 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 29, 2019
CompletedFirst Submitted
Initial submission to the registry
May 15, 2019
CompletedFirst Posted
Study publicly available on registry
August 8, 2019
CompletedAugust 9, 2019
August 1, 2019
4 days
May 15, 2019
August 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Cognitive test results
The results of cognitive test performed during inhalation of defined concentration of nitrous oxide. Cognitive tests: Digit Symbol Substitution Test (DSST).
Through study completion, an average of 1 year
Reaction Time
The results of reaction time test performed during inhalation of defined concentration of nitrous oxide. Reaction Time (in seconds) using a computer-based test.
Through study completion, an average of 1 year
Study Arms (7)
Control group - air
PLACEBO COMPARATORBreathing air with 21 % of oxygen (0% nitrous oxide). Performing cognitive tests as per protocol.
Intervention Group - 5% nitrous oxide
EXPERIMENTALBreathing 5% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 7% nitrous oxide
EXPERIMENTALBreathing 7% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 10% nitrous oxide
EXPERIMENTALBreathing 10% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 12% nitrous oxide
EXPERIMENTALBreathing 12% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 15% nitrous oxide
EXPERIMENTALBreathing 15% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Intervention Group - 20% nitrous oxide
EXPERIMENTALBreathing 20% nitrous oxide in air with 21 % of oxygen. Performing cognitive tests as per protocol.
Interventions
Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.
Eligibility Criteria
You may qualify if:
- healthy volunteers from the Czech Technical University
You may not qualify if:
- pregnancy
- allergy to nitrous oxide
- severe asthma or other severe respiratory conditions
- severe cardiovascular conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Czech Technical University
Prague, Czechia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karel Roubik, prof., Ph.D.
Czech Technical University in Prague
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2019
First Posted
August 8, 2019
Study Start
April 25, 2019
Primary Completion
April 29, 2019
Study Completion
April 29, 2019
Last Updated
August 9, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share