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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females who are between 18 and 40 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up derived from eegs recorded for 30-45 mins
Awards & highlights
Study Summary
This trial will attempt to identify if there is a relationship between vestibular signals and anxiety by studying the effects of two different drugs known to reduce the theta rhythm.
Who is the study for?
This trial is for men and women aged 18-40 without a history of substance use disorders, neurological illnesses, major hearing loss, or severe allergies. They shouldn't be pregnant, left-handed, colorblind, have had psychological treatment or taken psychiatric drugs in the past year.Check my eligibility
What is being tested?
The study tests if non-invasive EVestG technology can detect anxiety by measuring hippocampal theta rhythms from the ear canal. Participants will receive Buspirone or Triazolam (both known to reduce theta rhythm) versus a placebo in a double-blind setup.See study design
What are the potential side effects?
Potential side effects include dizziness, nausea, headache from Buspirone; drowsiness, memory issues from Triazolam; and no active side effects expected from the placebo.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 40 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ derived from eegs recorded for 30-45 mins
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~derived from eegs recorded for 30-45 mins
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
4-12 Hz modulation
EEG power spectrum
Secondary outcome measures
Signal correlations
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: TriazolamExperimental Treatment1 Intervention
Participants will receive triazolam 0.25 mg prior to experiments.
Group II: BuspironeExperimental Treatment1 Intervention
Participants will receive buspirone 10 mg prior to experiments.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a placebo prior to experiments.
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
597 Previous Clinical Trials
199,430 Total Patients Enrolled
8 Trials studying Anxiety
562 Patients Enrolled for Anxiety
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 40 years old.You have a history of drug or alcohol addiction, or someone in your family has a history of addiction.I have heart, lung disease, or diabetes.I have skin lesions in my ear canal.I have COPD or sleep apnea.I have kidney or liver problems.I am not taking antibiotics or supplements that affect CYP3A4 or CYP2D6.You are pregnant, breastfeeding, left-handed, or have difficulty seeing certain colors.I have been in psychological treatment or taken psychiatric drugs in the past year.You have had allergic reactions on your skin to things like soaps or cleaning products.You have not been diagnosed with any balance problems, as determined by a test performed by the doctor.I am currently experiencing symptoms similar to the flu or COVID-19.I am not taking any medications that could interfere with the study drugs.I am currently recovering from an accident, injury, or surgery.I have or had a neurological illness.I have a history of stroke, head injury, loss of consciousness, or epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Triazolam
- Group 2: Buspirone
- Group 3: Placebo
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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