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The Role of the LC-NA System in Experimental Sleep Fragmentation

NCT ID: NCT07167316

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-05

Study Completion Date

2026-10-01

Brief Summary

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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.

Detailed Description

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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 auditory stimuli to induce fragmentation. To investigate potential counteracting effects on sleep quality, participants receive either a low dose (64 µg), a high dose (96 µg) of dexmedetomidine (DMTN)-a compound known to reduce norepinephrine levels-or a placebo. All participants experience each condition in a randomized, double-blind, crossover design, with the sequence of administration varying between individuals. Neither the participants nor the study team are aware of the assigned condition on any given night.

In a second part of the study, three additional nights are conducted to assess the pharmacokinetics and pharmacodynamics of dexmedetomidine. During these nights, participants again receive either the low dose (64 µg), high dose (96 µg), or placebo (in randomized order). Blood samples are collected at multiple time points to characterize the compound's pharmacokinetic profile, and additional physiological outcomes are measured to evaluate pharmacodynamic effects.

Conditions

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The Role of the LC-NA System in Sleep Regulation

Keywords

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Cross-Over placebo controlled randomized sleep disturbance auditory stimulation healthy Stress LC-NA pharmacokinetics pharmacodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each participant will first spend a screening night to adapt to the sleep laboratory environment, followed by a baseline night without any interventions. Subsequently, they will complete three experimental nights, during which sleep will be disrupted using auditory stimulation. On each of these nights, participants will receive either a high dose, a low dose of dexmedetomidine, or a placebo. The order in which these three conditions are administered will be randomized across participants. In a second part of the study, participants will spend three nights again receiving the high dose, low dose, or placebo in randomized order. During these nights, blood samples will be collected for pharmacokinetic analyses, and additional physiological measures will be recorded to assess pharmacodynamic effects.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low Dose

Experimental: 64 µg Dexmedetomidine

Group Type EXPERIMENTAL

DMTN

Intervention Type DRUG

Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that reduces the release of norepinephrine by inhibiting activity in the locus coeruleus, a key brain region involved in arousal and stress responses. In this study, dexmedetomidine will be administered as an oro-dispersible tablet applied buccally, allowing for rapid absorption through the oral mucosa.

High Dose

Experimental: 96 µg Dexmedetomidine

Group Type EXPERIMENTAL

DMTN

Intervention Type DRUG

Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that reduces the release of norepinephrine by inhibiting activity in the locus coeruleus, a key brain region involved in arousal and stress responses. In this study, dexmedetomidine will be administered as an oro-dispersible tablet applied buccally, allowing for rapid absorption through the oral mucosa.

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placbo

Intervention Type DRUG

Oro-dispersible placebo tablet identical in appearance and packaging to the active Dexmedetomidine tablet.

Low Dose + Auditory Stimulation

Experimental: 64 µg Dexmedetomidine + Auditory Stimulation

Group Type EXPERIMENTAL

DMTN

Intervention Type DRUG

Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that reduces the release of norepinephrine by inhibiting activity in the locus coeruleus, a key brain region involved in arousal and stress responses. In this study, dexmedetomidine will be administered as an oro-dispersible tablet applied buccally, allowing for rapid absorption through the oral mucosa.

Auditory Stimulation

Intervention Type OTHER

Auditory tones will be presented throughout the night at individually calibrated intensities, adjusted to each participant's hearing threshold, in order to induce controlled sleep fragmentation without full awakenings.

High Dose + Auditory Stimulation

Experimental: 96 µg Dexmedetomidine + Auditory Stimulation

Group Type EXPERIMENTAL

DMTN

Intervention Type DRUG

Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that reduces the release of norepinephrine by inhibiting activity in the locus coeruleus, a key brain region involved in arousal and stress responses. In this study, dexmedetomidine will be administered as an oro-dispersible tablet applied buccally, allowing for rapid absorption through the oral mucosa.

Auditory Stimulation

Intervention Type OTHER

Auditory tones will be presented throughout the night at individually calibrated intensities, adjusted to each participant's hearing threshold, in order to induce controlled sleep fragmentation without full awakenings.

Placebo + Auditory Stimulation

Placebo + Auditory Stimulation

Group Type PLACEBO_COMPARATOR

Auditory Stimulation

Intervention Type OTHER

Auditory tones will be presented throughout the night at individually calibrated intensities, adjusted to each participant's hearing threshold, in order to induce controlled sleep fragmentation without full awakenings.

Placbo

Intervention Type DRUG

Oro-dispersible placebo tablet identical in appearance and packaging to the active Dexmedetomidine tablet.

Interventions

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DMTN

Dexmedetomidine is a highly selective alpha-2 adrenergic receptor agonist that reduces the release of norepinephrine by inhibiting activity in the locus coeruleus, a key brain region involved in arousal and stress responses. In this study, dexmedetomidine will be administered as an oro-dispersible tablet applied buccally, allowing for rapid absorption through the oral mucosa.

Intervention Type DRUG

Auditory Stimulation

Auditory tones will be presented throughout the night at individually calibrated intensities, adjusted to each participant's hearing threshold, in order to induce controlled sleep fragmentation without full awakenings.

Intervention Type OTHER

Placbo

Oro-dispersible placebo tablet identical in appearance and packaging to the active Dexmedetomidine tablet.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wellcome Trust

OTHER

Sponsor Role collaborator

Hans-Peter Landolt

OTHER

Sponsor Role lead

Responsible Party

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Hans-Peter Landolt

Prof. Dr. sc. nat.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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University of Zurich, Institute of Pharmacology and Toxicology

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Rafael Wespi, PhD

Role: CONTACT

Phone: +41 44 635 59 61

Email: [email protected]

Facility Contacts

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Rafael Wespi, PhD.

Role: primary

Patricia Sonderegger, MSc

Role: backup

Related Links

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https://pmc.ncbi.nlm.nih.gov/articles/PMC11801451/

Paper of our previous research project, providing the background for the current study

Other Identifiers

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2025-01005

Identifier Type: -

Identifier Source: org_study_id