Status:
NOT_YET_RECRUITING
The Role of the LC-NA System in Experimental Sleep Fragmentation
Lead Sponsor:
Hans-Peter Landolt
Collaborating Sponsors:
Wellcome Trust
Conditions:
The Role of the LC-NA System in Sleep Regulation
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief 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 sufficientl...
Detailed Description
Following a screening night and a baseline sleep recording, participants undergo three experimental nights in the sleep laboratory. On each of these nights, sleep is intentionally disrupted using audi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 5 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07167316
Start Date
January 5 2026
End Date
October 1 2026
Last Update
December 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Zurich, Institute of Pharmacology and Toxicology
Zurich, Switzerland, 8057