Understanding the Role of the Locus Coeruleus in Insomnia

NCT07392177 | Not Yet Recruiting Phase 2

• 1 other identifier: 19522
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia

Keywords

Electroencephalography; Sleep; Locus coeruleus; Hyperarousal

Outcome Measures

Primary Outcomes (1)

• Electrographic (EEG) signatures

  Electrographic (EEG) infraslow oscillations (\~50 sec) of sigma power and sleep spindle coupling during non-rapid eye movement (NREM) sleep and theta power during rapid eye movement (REM) sleep.

  Baseline and 14 days

Secondary Outcomes (7)

• Sleep Fragmentation

  Baseline and 14 days

• EEG power

  Baseline and 14 days

• Neurovascular activity (fNIRS)

  Baseline and 14 days

• Cardiopulmonary Coupling (CPC)

  Baseline and 14 days

• Pupillometry

  Baseline and 14 days

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

A 96 µg dexmedetomidine tablet taken during the sleep laboratory visit only

Drug: Dexmedetomidine

Placebo

ACTIVE COMPARATOR

Matching placebo tablet taken during the sleep laboratory visit only

Drug: Placebo

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine

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.

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Woolcock Institute of Medical Research: lead

Study Sites (1)

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, 2113, Australia

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Christopher Gordon, PhD

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

• Brendon Yee, MBChB, PhD

  Woolcock Institute of Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Gordon, PhD

CONTACT

+61 2 9805 3096; c.gordon@mq.edu.au

Camilla Hoyos, PhD

CONTACT

camilla.hoyos@mq.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All trial staff (except one unblinded researcher) and participants will be blinded to the intervention and control medication. We will use identical containers and labels except a patient identification code. The order of treatments will be secured in a password-protected data management system and known by the unblinded researcher.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Leader

Model Details: Double-blind, randomised, placebo-controlled crossover study

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: February 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Non-identifiable IPD will become available one year after the Actual Study Completion Date and will be available for ten years.
• Access Criteria: A copy of the non-identifiable dataset may be requested by academic collaborators not affiliated with the Woolcock Institute of Medical Research through a data request form which outlines the investigators, aims and hypotheses, data to be included, a statistical analysis plan, ethics approval, and security measures. Contact the Coordinating Principal Investigator for access to data.

Locations

AU (1)