Understanding the Role of the Locus Coeruleus in Insomnia

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Insomnia

In brief

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.

Key facts

Study ID

NCT07392177

Run by

Woolcock Institute of Medical Research

People needed

15

Starts

2026-02-01

Expected to finish

2027-03-01

Last updated by the study team

2026-02-06

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of insomnia disorder (DSM-5-TR)
• Insomnia severity index (ISI) score ≥15
• Able to provide informed consent
• Fluent English literacy

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.