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Completed

NCT Number: NCT04884893

Effect of Nitrous Oxide on EEG

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.

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Key information

Conditions

Nitrous Oxide Anesthetic, Inhalation Electroencephalography Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tampere University Hospital

Tampere, 33521, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrous Oxide

Drug

50% nitrous oxide

Primary outcomes

  1. Slow wave activity

    Time frame: During nitrous oxide administration

    Delta wave in EEG

  2. Slow wave activity

    Time frame: Following 20 minutes after nitrous oxide administration

    Delta wave in EEG

Secondary outcomes

  1. Self-reported psychiatric symptoms

    Time frame: 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

    Time frame: Baseline, 20 minutes after nitrous oxide

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

  3. Side effects - restlessness

    Time frame: 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

    Time frame: 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

    Time frame: Baseline, 20 minutes after nitrous oxide

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

  6. Side effects - tension

    Time frame: Baseline, 20 minutes after nitrous oxide

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

  7. Side effects - uneasiness

    Time frame: Baseline, 20 minutes after nitrous oxide

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

  8. Side effects - tiredness

    Time frame: Baseline, 20 minutes after nitrous oxide

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

  9. Side effects - numbness

    Time frame: Baseline, 20 minutes after nitrous oxide

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

  10. Side effects - dizziness

    Time frame: Baseline, 20 minutes after nitrous oxide

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

  11. Side effects - agitation

    Time frame: Baseline, 20 minutes after nitrous oxide

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

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Tampere University
  • University of Helsinki

Registry information

Official study title

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

Acronym: HUMANOID

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 13, 2021
Registry last updated
Dec 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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