Informazioni generali
  • Categoria della malattia Altro (BASEC)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Zurigo
    (BASEC)
  • Responsabile dello studio Prof. Dr. Nicole Wenderoth Dr. Sarah Meissner nicole.wenderoth@hest.ethz.ch (BASEC)
  • Fonte dati BASEC: Importato da 08.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 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

  • Categoria della malattia Altro (BASEC)
  • Stato di reclutamento reclutamento in corso (BASEC/ICTRP)
  • Luogo dello studio
    Zurigo
    (BASEC)
  • Responsabile dello studio Prof. Dr. Nicole Wenderoth Dr. Sarah Meissner nicole.wenderoth@hest.ethz.ch (BASEC)
  • Fonte dati BASEC: Importato da 08.07.2025 ICTRP: N/A
  • Ultimo aggiornamento 08.07.2025 16:25

Descrizione riassuntiva dello studio

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)

Intervento studiato

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)

Malattie studiate

In this project, only healthy participants are examined.

(BASEC)

Criteri di partecipazione
- Healthy participants - Age 18 – 50 years - Normal physical and mental health (self-report) (BASEC)

Criteri di esclusione
• 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)

Luogo dello studio

Zurigo

(BASEC)

non disponibile

Sponsor

NA

(BASEC)

Contatto per ulteriori informazioni sullo studio

Persona di contatto in Svizzera

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)

Informazioni scientifiche

non disponibile

Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)

Commissione etica Zurigo

(BASEC)

Data di approvazione del comitato etico

06.12.2024

(BASEC)


ID di studio ICTRP
non disponibile

Titolo ufficiale (approvato dal comitato etico)
Investigating the Role of the Locus Coeruleus-Noradrenaline System in Arousal Control during Wake and Sleep (BASEC)

Titolo accademico
non disponibile

Titolo pubblico
non disponibile

Malattie studiate
non disponibile

Intervento studiato
non disponibile

Tipo di studio
non disponibile

Disegno dello studio
non disponibile

Criteri di inclusione/esclusione
non disponibile

non disponibile

Endpoint primari e secondari
non disponibile

non disponibile

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
non disponibile

ID secondari
non disponibile

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
non disponibile

Risultati dello studio

Riepilogo dei risultati

non disponibile

Link ai risultati nel registro primario

non disponibile