HUMANOID: Effect of Nitrous Oxide on EEG

• Sponsor: Tampere University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04884893
• Collaborator: Tampere University (Other), University of Helsinki (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.1
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nitrous Oxide; Electroencephalography; Anesthetic, Inhalation	Drug: Nitrous Oxide	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effect of Nitrous Oxide on EEG, a Randomized, Double-blinded Study
• Actual Study Start Date: May 21, 2021
• Actual Primary Completion Date: Sep 24, 2021
• Actual Study Completion Date: Sep 24, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Slow wave activity [During nitrous oxide administration]

   Delta wave in EEG

2. Slow wave activity [Following 20 minutes after nitrous oxide administration]

   Delta wave in EEG

Secondary Outcome Measures

1. Self-reported psychiatric symptoms [Baseline, 20 minutes after nitrous oxide]

   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.

2. Side effects - anxiety [Baseline, 20 minutes after nitrous oxide]

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

3. Side effects - restlessness [Baseline, 20 minutes after nitrous oxide]

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

4. Side effects - mood elevation [Baseline, 20 minutes after nitrous oxide]

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

5. Side effects - nausea [Baseline, 20 minutes after nitrous oxide]

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

6. Side effects - tension [Baseline, 20 minutes after nitrous oxide]

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

7. Side effects - uneasiness [Baseline, 20 minutes after nitrous oxide]

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

8. Side effects - tiredness [Baseline, 20 minutes after nitrous oxide]

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

9. Side effects - numbness [Baseline, 20 minutes after nitrous oxide]

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

10. Side effects - dizziness [Baseline, 20 minutes after nitrous oxide]

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

11. Side effects - agitation [Baseline, 20 minutes after nitrous oxide]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tampere University Hospital	Tampere		Finland	33521

Sponsors and Collaborators

• Tampere University Hospital
• Tampere University
• University of Helsinki

Investigators

• Principal Investigator: Maija-Liisa Kalliomäki, MD, PhD, Tampere University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tampere University Hospital
• ClinicalTrials.gov Identifier: NCT04884893
• Other Study ID Numbers: R18097M
• First Posted: May 13, 2021
• Last Update Posted: Dec 10, 2021
• Last Verified: Mar 1, 2021

• 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
• Keywords provided by Tampere University Hospital: EEG; Slow wave activity; Nitrous oxide; N-methyl-D-aspartate-receptor blockade; Delta wave; Self-reported psychiatric symptoms
• Additional relevant MeSH terms: Respiratory Aspiration; Nitrous Oxide

Study Results

No Results Posted as of Dec 10, 2021