Effect of Nitrous Oxide on EEG

Electroencephalography Clinical Trial

— HUMANOID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884893
• Other study ID #: R18097M
• Status: Completed
• Phase: Phase 1
• Start date: May 21, 2021
• Est. completion date: September 24, 2021

Study information

• Verified date: March 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 24, 2021
• Est. primary completion date: September 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Electroencephalography
• Nitrous Oxide
• Respiratory Aspiration

Intervention

Drug:
• Nitrous Oxide
50% nitrous oxide

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Tampere University, University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slow wave activity	Delta wave in EEG	During nitrous oxide administration
Primary	Slow wave activity	Delta wave in EEG	Following 20 minutes after nitrous oxide administration
Secondary	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
Secondary	Side effects - anxiety	Self reported anxiety on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Secondary	Side effects - restlessness	Self reported restlessness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Secondary	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
Secondary	Side effects - nausea	Self reported nausea on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Secondary	Side effects - tension	Self reported tension on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Secondary	Side effects - uneasiness	Self reported uneasiness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Secondary	Side effects - tiredness	Self reported tiredness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Secondary	Side effects - numbness	Self reported numbness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Secondary	Side effects - dizziness	Self reported dizziness on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide
Secondary	Side effects - agitation	Self reported agitation on a 0 (no at all) to 5 (very much) scale	Baseline, 20 minutes after nitrous oxide