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Effect of Nitrous Oxide on EEG (HUMANOID)

Primary Purpose

Nitrous Oxide, Electroencephalography, Anesthetic, Inhalation

Status

Completed

Phase

Phase 1

Locations

Finland

Study Type

Interventional

Intervention

Nitrous Oxide

About this trial

This is an interventional basic science trial for Nitrous Oxide focused on measuring EEG, Slow wave activity, Nitrous oxide, N-methyl-D-aspartate-receptor blockade, Delta wave, Self-reported psychiatric symptoms

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

informed consent obtained
age between 18 - 40
male
body mass index 18 - 27

Exclusion Criteria:

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

Sites / Locations

Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intermittent nitrous oxide

Continuous nitrous oxide

Arm Description

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

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

Outcomes

Primary Outcome Measures

Slow wave activity

Delta wave in EEG

Slow wave activity

Delta wave in EEG

Secondary Outcome Measures

Self-reported psychiatric symptoms

Symptom Check List 90 (SCL-90) is a self-reported questionnaire measuring psychological stress. Results are normed, meaning that test scores can be compared to Finnish reference values. In this study we measure if there is an increase in self-reported psychiatric symptoms after nitrous oxide administration.

Side effects - anxiety

Self reported anxiety on a 0 (no at all) to 5 (very much) scale

Side effects - restlessness

Self reported restlessness on a 0 (no at all) to 5 (very much) scale

Side effects - mood elevation

Self reported mood elevation on a 0 (no at all) to 5 (very much) scale

Side effects - nausea

Self reported nausea on a 0 (no at all) to 5 (very much) scale

Side effects - tension

Self reported tension on a 0 (no at all) to 5 (very much) scale

Side effects - uneasiness

Self reported uneasiness on a 0 (no at all) to 5 (very much) scale

Side effects - tiredness

Self reported tiredness on a 0 (no at all) to 5 (very much) scale

Side effects - numbness

Self reported numbness on a 0 (no at all) to 5 (very much) scale

Side effects - dizziness

Self reported dizziness on a 0 (no at all) to 5 (very much) scale

Side effects - agitation

Self reported agitation on a 0 (no at all) to 5 (very much) scale

Full Information

NCT ID

NCT04884893

First Posted

March 9, 2021

Last Updated

December 9, 2021

Sponsor

Tampere University Hospital

Collaborators

Tampere University, University of Helsinki

1. Study Identification

Unique Protocol Identification Number

NCT04884893

Brief Title

Effect of Nitrous Oxide on EEG

Acronym

HUMANOID

Official Title

The Effect of Nitrous Oxide on EEG, a Randomized, Double-blinded Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

May 21, 2021 (Actual)

Primary Completion Date

September 24, 2021 (Actual)

Study Completion Date

September 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tampere University Hospital

Collaborators

Tampere University, University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nitrous Oxide, Electroencephalography, Anesthetic, Inhalation

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intermittent nitrous oxide

Arm Type

Experimental

Arm Description

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

Arm Title

Continuous nitrous oxide

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nitrous Oxide

Intervention Description

50% nitrous oxide

Primary Outcome Measure Information:

Title

Slow wave activity

Description

Delta wave in EEG

Time Frame

During nitrous oxide administration

Title

Slow wave activity

Description

Delta wave in EEG

Time Frame

Following 20 minutes after nitrous oxide administration

Secondary Outcome Measure Information:

Title

Self-reported psychiatric symptoms

Description

Time Frame