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NOT YET RECRUITING
NCT07392177
PHASE2

Understanding the Role of the Locus Coeruleus in Insomnia

Sponsor: Woolcock Institute of Medical Research

View on ClinicalTrials.gov

Summary

This research project aims to better understand the neurobiological mechanistic underpinnings of insomnia disorder. The main question is whether cortical hyperarousal in individuals with insomnia disorder, measured by electroencephalograhic (EEG) infraslow oscillation coupling of sigma power during non-rapid eye movement (NREM) sleep and theta power during rapid eye movement (REM) sleep, is related to locus coeruleus activity.

Official title: An Alpha2-adrenoceptor Agonist to Reduce Locus Coeruleus Activity During Sleep in Adults With Insomnia Disorder: a Pilot Randomised Placebo-controlled Cross-over Study

Key Details

Gender

All

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-02

Completion Date

2027-03

Last Updated

2026-02-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dexmedetomidine

A buccal tablet containing 96 µg dexmedetomidine will be taken before habitual bedtime.

DRUG

Placebo

Placebo tablets will contain identical excipient without the active ingredient (dexmedetomidine) and manufactured under the same condition as the active. Placebo tablets, packs and instructions will be identical in every respect to enable the double-blind study design.

Locations (1)

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia