Understanding the Role of the Locus Coeruleus in Insomnia

Sponsor
Woolcock Institute of Medical Research
Study ID
NCT07392177
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

First listed
Feb 6, 2026
Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Dexmedetomidine
    A 96 µg dexmedetomidine tablet taken during the sleep laboratory visit only
  • Active Comparator: Placebo
    Matching placebo tablet taken during the sleep laboratory visit only

Primary Outcome Measure

Electrographic (EEG) signatures [ Time Frame: Baseline and 14 days ]

Central Contacts

Find similar trials

Nationwide
Insomnia trialsMental health trialsSleep medicine trials

Related Studies