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Understanding the Role of the Locus Coeruleus in Insomnia

NCT07392177 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-02-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Woolcock Institute of Medical Research

    lead OTHER

Principal Investigators

  • Christopher Gordon, PhD · Woolcock Institute of Medical Research

  • Brendon Yee, MBChB, PhD · Woolcock Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Australia

Study Locations

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392177 on ClinicalTrials.gov