Health TrialsbyHealthPanel

Understanding the Role of the Locus Coeruleus in Insomnia

ConditionInsomnia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30-65
SponsorWoolcock Institute of Medical Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of insomnia disorder (DSM-5-TR)

Insomnia severity index (ISI) score ≥15

Able to provide informed consent

Fluent English literacy

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: DexmedetomidineExperimental treatment 1 intervention
Group B: PlaceboActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline and 14 days

Secondary outcomes

1

Sleep Fragmentation

Polysomnography (PSG) measure conducted during the intervention and control (wake after sleep onset)

Time frame
Baseline and 14 days
2

EEG power

Electroencephalographic (EEG) power during non-rapid eye movement (NREM) (stages 2 and 3) and rapid eye movement (REM) sleep. Unit of measurement is μV\^2.

Time frame
Baseline and 14 days
3

Neurovascular activity (fNIRS)

Measurement of global blood flow using functional near-infrared spectroscopy (fNIRS).

Time frame
Baseline and 14 days
4

Cardiopulmonary Coupling (CPC)

Cardiopulmonary coupling provides a global measure of autonomic function

Time frame
Baseline and 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Woolcock Institute of Medical Research

Lead sponsor

Source ClinicalTrials.gov
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