Can a mouth film reveal the secret to restful sleep?
NCT ID NCT07167316
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how a brain chemical called norepinephrine affects sleep. Healthy adults aged 18-35 will receive a buccal (mouth film) dose of dexmedetomidine or a placebo to see how it changes sleep patterns. The goal is to better understand sleep regulation, not to treat a disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 35 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age between 18 - 35 years (inclusive) * Body-Mass-Index (BMI): 18.5 \< BMI \< 25 * Non-nicotine user status * Habitual consumption of 5 or fewer alcoholic beverages / week * Habitual consumption of 3 or fewer caffeinated beverages / day * Habitual average sleep duration 7-9 h / night * Normal or corrected-to-normal vision * Insomnia severity Index (ISI) Score: ISI \< 8 * Ability to understand and speak German language * Normal hearing ability (applies only to Sleep Study Part) * Ability and willingness to provide informed consent as documented by dated signature Exclusion Criteria: * Present use of medication that may interfere with sleep or study drugs * Travel across 3 or more time zones within 3 months of study start * Habitual napping * Extreme chronotype, determined by reduced Morningness-Eveningness Questionnaire (rMEQ) score: 8 \< rMEQ \> 21) * Shift working within 2 weeks prior to the screening visit * History of or presence of a trauma- or stressor-related disorder * Serious acute or chronic neurological, mental, or general medical conditions that, in the opinion of the investigator, may pose a risk to participation or affect study measurements * History of or presence of a sleep wake disorder * Use of illicit drugs (positive urinary drug screening) * Male participants who are not vasectomised for at least 6 months prior to dosing and who are sexually active with a female partner of childbearing potential not willing to use one of the following acceptable contraceptive methods from the first dose and for 3 months after the last dose: Use of condom and/or hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner; * Male participants (including men who have had a vasectomy) with a pregnant partner not willing to use a condom from the first dose and for 3 months after the last dose. * Male participants not willing to abstain from sperm donation for 3 months after the last dose * Females of childbearing potential who are sexually active with a non-sterile male partner (sterile male partners are defined as men vasectomised at least 6 months prior to the first study drug administration) not willing to use one of the following acceptable contraceptive methods throughout the study and for at least 3 months after the last study drug administration: Simultaneous use of condom and hormonal contraceptive (e.g., oral, patch, depot injection, implant, vaginal ring, intrauterine device) or non-hormonal intrauterine device used for at least 4 weeks prior to sexual intercourse for the female partner; \- Females of non-childbearing potential who are neither: Post-menopausal (status defined as an absence of menses for at least 12 months prior to the first study drug administration); or Surgically sterilized (complete hysterectomy or bilateral oophorectomy at least 3 months prior to the first study drug administration) * Faints at the sight of blood (applies only for the pharmacokinetic-part of the study) * Has participated in a study \< 30 days or a study such as this (i.e., experimental trauma) at all.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Zurich, Institute of Pharmacology and Toxicology
RECRUITINGZurich, 8057, Switzerland