Understanding the Locus Coeruleus in Insomnia
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
Run by Woolcock Institute of Medical Research · NCT07392177 · Data updated 2026-11-12
This study tests whether a brain chemical blocker (dexmedetomidine) or placebo can reveal how the locus coeruleus relates to insomnia in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Woolcock Institute of Medical Research Academic / other |
| Locations | 1 site (Macquarie Park, New South Wales) |
| Status | Recruiting |
| Started | August 12, 2026 |
| Main results expected | March 2027 |
| Study ends | March 2027 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT07392177 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with DSM-5-TR diagnosed insomnia disorder and ISI score ≥15 who are fluent in English and can consent.
✕Probably not a fit
Individuals with other sleep disorders, significant psychiatric or medical instability, or those unable to complete the lab-based procedures may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, double-blind, placebo-controlled, cross-over trial will compare dexmedetomidine versus placebo in adults with insomnia disorder. Participants will undergo sleep lab visits with EEG, fNIRS, and pupillometry to measure brain activity before and during sleep, alongside subjective measures of arousal. The study aims to link brainstem noradrenergic activity to cortical arousal patterns in NREM and REM sleep and to see if dexmedetomidine modulates these signals. Recruitment is via clinics, social media, and notices, with online pre-screening and in-person assessments before randomization. A 14-day washout separates the two sleep lab sessions, each including pre-sleep measurements and sleep monitoring.
Why it matters
Potential benefit: If successful, the study could clarify mechanisms linking locus coeruleus activity to insomnia and suggest targeted approaches for symptom relief.
How similar studies have gone: Prior work has explored noradrenergic modulation in sleep, but this exact cross-over, lab-based mechanistic study in insomnia is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia Recruiting
Study contacts
- Principal investigator: Christopher Gordon, PhD — Woolcock Institute of Medical Research
- Study coordinator: Christopher Gordon, PhD
- Email: c.gordon@mq.edu.au
- Phone: +61 2 9805 3096
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.