Nitrous OxidePhase 1HUMANOIDNCT04884893
Effect of Nitrous Oxide on EEG
A Phase 1 study testing Nitrous Oxide in people with Nitrous Oxide and Electroencephalography, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Nitrous Oxide, Electroencephalography, Anesthetic, Inhalation
- What is being tested?
- Nitrous Oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 21 May 2021to 24 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- informed consent obtained
- age between 18 - 40
- male
- body mass index 18 - 27
Who cannot join
- 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
Show all 9Show fewer
- Any heart illness
- Epilepsy
- Known vitamin B12 deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Nitrous Oxide
- Keywords
- EEG, Slow wave activity, Nitrous oxide, N-methyl-D-aspartate-receptor blockade, Delta wave, Self-reported psychiatric symptoms
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
50% nitrous oxide
| Study group | Role | What they receive |
|---|---|---|
| Intermittent nitrous oxide | Experimental | 10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen Receives: Drug: Nitrous Oxide |
| Continuous nitrous oxide | Experimental | 20 min 50% nitrous oxide + 20 min 100% oxygen Receives: Drug: Nitrous Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slow wave activity
Delta wave in EEG
Measured: During nitrous oxide administration
Slow wave activity
Delta wave in EEG
Measured: Following 20 minutes after nitrous oxide administration
Secondary outcomes (11)
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.
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - anxiety
Self reported anxiety on a 0 (no at all) to 5 (very much) scale
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - restlessness
Self reported restlessness on a 0 (no at all) to 5 (very much) scale
Measured: 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
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - nausea
Self reported nausea on a 0 (no at all) to 5 (very much) scale
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - tension
Self reported tension on a 0 (no at all) to 5 (very much) scale
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - uneasiness
Self reported uneasiness on a 0 (no at all) to 5 (very much) scale
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - tiredness
Self reported tiredness on a 0 (no at all) to 5 (very much) scale
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - numbness
Self reported numbness on a 0 (no at all) to 5 (very much) scale
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - dizziness
Self reported dizziness on a 0 (no at all) to 5 (very much) scale
Measured: Baseline, 20 minutes after nitrous oxide
Side effects - agitation
Self reported agitation on a 0 (no at all) to 5 (very much) scale
Measured: Baseline, 20 minutes after nitrous oxide
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start21 May 2021
- Primary completion24 Sep 2021
- Study completion24 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nitrous OxideStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Maija-Liisa Kalliomäki, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884893
- Sponsor's protocol ID
- R18097M
- Acronym
- HUMANOID
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nitrous Oxide on EEG, a Randomized, Double-blinded Study
- ClinicalTrials.gov ID
- NCT04884893
- Acronym / sponsor ID
- HUMANOID / R18097M
- Keywords
- EEG, Slow wave activity, Nitrous oxide, N-methyl-D-aspartate-receptor blockade, Delta wave, Self-reported psychiatric symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, University of Helsinki
- Study start
- 21 May 2021 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent nitrous oxide | Experimental | Drug: Nitrous Oxide10 minutes of 50% nitrous oxide + 10 min 100% oxygen + 10 min 50% nitrous oxide + 10 min 100% oxygen |
| Continuous nitrous oxide | Experimental | Drug: Nitrous Oxide20 min 50% nitrous oxide + 20 min 100% oxygen |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- informed consent obtained
- age between 18 - 40
- male
- body mass index 18 - 27
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous Oxide50% nitrous oxide | Drug | Continuous nitrous oxide, Intermittent nitrous oxide |
Primary outcome
Slow wave activity
Time frame: During nitrous oxide administration
Delta wave in EEG
Slow wave activity
Time frame: Following 20 minutes after nitrous oxide administration
Delta wave in EEG
11 secondary outcomes
Self-reported psychiatric symptoms
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - anxiety
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - restlessness
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - mood elevation
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - nausea
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - tension
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - uneasiness
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - tiredness
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - numbness
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - dizziness
Time frame: Baseline, 20 minutes after nitrous oxide
Side effects - agitation
Time frame: Baseline, 20 minutes after nitrous oxide
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maija-Liisa Kalliomäki, MD, PhD principal investigator
Tampere University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nitrous Oxide in people with Nitrous Oxide and Electroencephalography, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slow wave activity (time frame: During nitrous oxide administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.