Effect of Nitrous Oxide on EEG (HUMANOID)

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

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.

Study Overview

• Status: Completed
• Conditions: Electroencephalography; Nitrous Oxide; Anesthetic, Inhalation
• Intervention / Treatment: Drug: Nitrous Oxide

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33521
    • Tampere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent nitrous oxide; 10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen	Drug: Nitrous Oxide; 50% nitrous oxide
Experimental: Continuous nitrous oxide; 20 min 50% nitrous oxide + 20 min 100% oxygen	Drug: Nitrous Oxide; 50% nitrous oxide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slow wave activity	Delta wave in EEG	During nitrous oxide administration
Slow wave activity	Delta wave in EEG	Following 20 minutes after nitrous oxide administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 20 minutes after nitrous oxide
Side effects - anxiety	Self reported anxiety on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - restlessness	Self reported restlessness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - mood elevation	Self reported mood elevation on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - nausea	Self reported nausea on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - tension	Self reported tension on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - uneasiness	Self reported uneasiness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - tiredness	Self reported tiredness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - numbness	Self reported numbness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - dizziness	Self reported dizziness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Side effects - agitation	Self reported agitation on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: University of Helsinki; Tampere University
• Investigators: Principal Investigator: Maija-Liisa Kalliomäki, MD, PhD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): September 24, 2021
• Study Completion (Actual): September 24, 2021

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: EEG; Nitrous oxide; Slow wave activity; N-methyl-D-aspartate-receptor blockade; Delta wave; Self-reported psychiatric symptoms
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anesthetics, Inhalation; Nitrous Oxide
• Other Study ID Numbers: R18097M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No