RECRUITING Phase 2 ClinicalTrials.gov

Understanding the Role of the Locus Coeruleus in Insomnia

Sponsor: Woolcock Institute of Medical Research • ClinicalTrials.gov ID: NCT07392177

Registry updated: 2026-08-19

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Description

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.

Interventions

Dexmedetomidine (Drug)
A buccal tablet containing 96 µg dexmedetomidine will be taken before habitual bedtime.
Placebo (Drug)
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.

Eligibility criteria

Inclusion Criteria: * Diagnosis of insomnia disorder (DSM-5-TR) * Insomnia severity index (ISI) score ≥15 * Able to provide informed consent * Fluent English literacy Exclusion Criteria: * Medically diagnosis of sleep disordered breathing (i.e. sleep apnea) or sleep or circadian disorder other than insomnia * Uncontrolled psychiatric disorders * High dependence on medical care * History of, or current suicide ideation (Patient Health Questionnaire (PHQ-9) questionnaire) * Pregnancy or actively trying to conceive, or lactating * Shiftwork - defined as work outside of business hours (before 8am or after 6pm) conducted at least once per week * Travel across time zones of over 2 h time difference in the past week * Contraindicate the patient's participation in the clinical trial due to safety concerns or compliance with clinical study procedures * Concomitant use of medicines that are inhibitors, or moderate to strong inducers, of CYP3A4; regular use of hypnotics and other medications that can cause additive sedation or psychostimulants or non-amphetamine psychostimulants within 14 days of starting the clinical trial * Ongoing use of THC- or CBD-containing products; dependence or any other drug or alcohol dependence * Allergy to lactose

Conditions

Insomnia

Locations

Woolcock Institute of Medical Research — Macquarie Park, New South Wales, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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