MedDataX Logo

Effect of Nitrous Oxide on EEG

NCT ID: NCT04884893

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2021-09-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our recent preclinical observations suggest that monitoring of slow electroencephalogram (EEG) oscillations may be used to predict the efficacy of rapid-acting antidepressants such as ketamine or nitrous oxide. In this project we will carry out critical clinical research on healthy volunteers and study the effects of nitrous oxide on EEG. Results will be used for the design of clinical trials on depressed individuals. The project will be done in collaboration between neuroscientists at the University of Helsinki and clinicians at the Tampere University Hospital.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nitrous Oxide Electroencephalography Anesthetic, Inhalation

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

EEG Slow wave activity Nitrous oxide N-methyl-D-aspartate-receptor blockade Delta wave Self-reported psychiatric symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intermittent nitrous oxide

10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

50% nitrous oxide

Continuous nitrous oxide

20 min 50% nitrous oxide + 20 min 100% oxygen

Group Type EXPERIMENTAL

Nitrous Oxide

Intervention Type DRUG

50% nitrous oxide

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nitrous Oxide

50% nitrous oxide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. informed consent obtained
2. age between 18 - 40
3. male
4. body mass index 18 - 27

Exclusion Criteria

1. Age \< 18 or \> 40
2. Alcohol Use Disorders Identification Test (AUDIT) \>6 points
3. Drug Abuse Screening Test 20 (DAST-20) \> 0 points
4. Beck Depression Inventory (BDI) \> 11 points
5. Symptom Check List 90 (SCL-90) over mean values of Finnish population in any dimensions of the SCL-90 or the global severity index
6. Any respiratory disorder including sleep apnea
7. Any heart illness
8. Epilepsy
9. Known vitamin B12 deficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tampere University

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maija-Liisa Kalliomäki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tampere University Hospital

Tampere, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R18097M

Identifier Type: -

Identifier Source: org_study_id