Effect of Nitrous Oxide on EEG
- Conditions
- ElectroencephalographyNitrous OxideAnesthetic, Inhalation
- Interventions
- Registration Number
- NCT04884893
- Lead Sponsor
- Tampere University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- informed consent obtained
- age between 18 - 40
- male
- body mass index 18 - 27
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent nitrous oxide Nitrous Oxide 10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen Continuous nitrous oxide Nitrous Oxide 20 min 50% nitrous oxide + 20 min 100% oxygen
- Primary Outcome Measures
Name Time Method Slow wave activity Following 20 minutes after nitrous oxide administration Delta wave in EEG
- Secondary Outcome Measures
Name Time Method 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.
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
Side effects - nausea Baseline, 20 minutes after nitrous oxide Self reported nausea on a 0 (no at all) to 5 (very much) scale
Side effects - agitation Baseline, 20 minutes after nitrous oxide Self reported agitation on a 0 (no at all) to 5 (very much) scale
Side effects - restlessness Baseline, 20 minutes after nitrous oxide Self reported restlessness on a 0 (no at all) to 5 (very much) scale
Side effects - tension Baseline, 20 minutes after nitrous oxide Self reported tension on a 0 (no at all) to 5 (very much) scale
Side effects - anxiety Baseline, 20 minutes after nitrous oxide Self reported anxiety on a 0 (no at all) to 5 (very much) scale
Side effects - uneasiness Baseline, 20 minutes after nitrous oxide Self reported uneasiness on a 0 (no at all) to 5 (very much) scale
Side effects - tiredness Baseline, 20 minutes after nitrous oxide Self reported tiredness on a 0 (no at all) to 5 (very much) scale
Side effects - numbness Baseline, 20 minutes after nitrous oxide Self reported numbness on a 0 (no at all) to 5 (very much) scale
Side effects - dizziness Baseline, 20 minutes after nitrous oxide Self reported dizziness on a 0 (no at all) to 5 (very much) scale
Trial Locations
- Locations (1)
Tampere University Hospital
🇫🇮Tampere, Finland