The Role of the LC-NA System in Experimental Sleep Fragmentation (NCT07167316) | Clinical Trial Compass
RecruitingPhase 1
The Role of the LC-NA System in Experimental Sleep Fragmentation
Switzerland42 participantsStarted 2026-05-21
Plain-language summary
Sleep-wake regulation affects every person's life, yet the molecular mechanisms underlying these processes remain poorly understood. In particular, the microstructure of sleep has not been sufficiently studied to explain how sleep produces a feeling of restoration the following morning. Stress also plays a significant role in sleep regulation. This study aims to investigate the role of norepinephrine in these processes.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 followi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Total Sleep Time (TST)
Timeframe: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
2
Change in Wake After Sleep Onset (WASO)
Timeframe: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
3
Change in Sleep Efficiency
Timeframe: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
4
Change in Sleep Onset Latency (SOL)
Timeframe: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
5
Percentage of Time in N1, N2, N3 and REM-Sleep
Timeframe: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
6
Change in Arousal Index
Timeframe: Baseline Night, Experimental Night 1, Experimental Night 2, Experimental Night 3
7
Maximum Plasma Concentration (Cmax) of Dexmedetomidine