Allgemeine Informationen
  • Krankheitskategorie Andere (BASEC)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Zürich
    (BASEC)
  • Studienverantwortliche Prof. Dr. Nicole Wenderoth Dr. Sarah Meissner nicole.wenderoth@hest.ethz.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 08.07.2025 ICTRP: N/A
  • Letzte Aktualisierung 08.07.2025 16:25
HumRes66160 | SNCTP000006197 | BASEC2024-01471

The role of the locus coeruleus-norepinephrine system in the regulation of arousal states during sleep and wakefulness

  • Krankheitskategorie Andere (BASEC)
  • Rekrutierungsstatus Rekrutierung läuft (BASEC/ICTRP)
  • Studienstandort
    Zürich
    (BASEC)
  • Studienverantwortliche Prof. Dr. Nicole Wenderoth Dr. Sarah Meissner nicole.wenderoth@hest.ethz.ch (BASEC)
  • Datenquelle(n) BASEC: Import vom 08.07.2025 ICTRP: N/A
  • Letzte Aktualisierung 08.07.2025 16:25

Zusammenfassung der Studie

The brain's arousal state is regulated by various neurotransmitter systems, particularly the noradrenergic locus coeruleus (LC) in the brainstem. The activity of the locus coeruleus and the resulting arousal state influence essential cognitive functions such as attention and memory, and are crucial for our well-being. High arousal levels have been associated with anxiety, sleep, and stress-related disorders. In recent studies, we have shown that individuals can voluntarily influence their arousal state during wakefulness through mental strategies in a pupil-based biofeedback training. Additionally, we have replicated animal studies that demonstrate that the brain's arousal state fluctuates significantly during certain sleep phases and that pupil size provides important insights into sleep phases, sleep continuity, and sleep dynamics. In the following study, we investigate in two experiments the causal role of the locus coeruleus-norepinephrine system in regulating the arousal state during wakefulness and sleep. We plan to explore this relationship by administering clonidine (trade name Catapresan®), a medication that reduces norepinephrine release in the central nervous system. The first experiment will provide insights into whether the voluntary control of arousal state during wakefulness is primarily governed by the norepinephrine system. The second experiment will examine whether the norepinephrine system is responsible for fluctuations in arousal state during different sleep phases. The results of this study are significant for understanding fundamental brain functions and could contribute to the development of non-invasive methods to enhance well-being during wakefulness as well as improve sleep quality.

(BASEC)

Untersuchte Intervention

In our study, participants are randomly assigned to groups. This is important to obtain reliable results from the study. This is called randomization. Each group receives a different treatment. In our study, there are two groups: • Group 1 (experimental group) receives the study medication clonidine at a dosage of 0.15 mg. • Group 2 (control group) receives a placebo, a vitamin C capsule at a dosage of 100 mg. The study is a so-called double-blind study. “Double-blind” means that no one involved in the conduct of the study knows which group the participants have been assigned to: the participants themselves do not know which group they are in. Even the testing person does not know which group individual participants belong to. In this sense, all participants are “blind.” The idea is to minimize any influence on the results. Through randomization and double-blinding, we can objectively assess how well the study medication clonidine actually works.

(BASEC)

Untersuchte Krankheit(en)

In this project, only healthy participants are examined.

(BASEC)

Kriterien zur Teilnahme
- Healthy participants - Age 18 – 50 years - Normal physical and mental health (self-report) (BASEC)

Ausschlusskriterien
• Eye-related disorders or diseases (e.g., eye infections, dry eyes, and/or light sensitivity) • Drug or alcohol abuse • Use of psychotropic medications and other drugs affecting the central nervous system (including clonidine for hypertension) (BASEC)

Studienstandort

Zürich

(BASEC)

nicht verfügbar

Sponsor

NA

(BASEC)

Kontakt für weitere Auskünfte zur Studie

Kontaktperson Schweiz

Prof. Dr. Nicole Wenderoth Dr. Sarah Meissner

+41 44 633 29 38

nicole.wenderoth@hest.ethz.ch

Department of Health Science and Technology ETH Zurich

(BASEC)

Wissenschaftliche Auskünfte

nicht verfügbar

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Zürich

(BASEC)

Datum der Bewilligung durch die Ethikkommission

06.12.2024

(BASEC)


ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
Investigating the Role of the Locus Coeruleus-Noradrenaline System in Arousal Control during Wake and Sleep (BASEC)

Wissenschaftlicher Titel
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Öffentlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Studientyp
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Studiendesign
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Registrierungsdatum
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Einschluss des ersten Teilnehmers
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Sekundäre Sponsoren
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Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
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Weitere Informationen zur Studie
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Ergebnisse der Studie

Zusammenfassung der Ergebnisse

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Link zu den Ergebnissen im Primärregister

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