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The Sleepless Brain: Neuroimaging Support for a Differential Diagnosis of Insomnia

The Sleepless Brain: Neuroimaging Support for a Differential Diagnosis of Insomnia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02821234
Acronym
SOMNET
Enrollment
40
Registered
2016-07-01
Start date
2016-09-01
Completion date
2017-04-03
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Insomnia, Hyperarousal

Brief summary

One-tenth of the population suffers from insomnia, increasing their risk on other health problems such as depression. Self-reported sleep quality only was historically leading for insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated with insomnia, either physiological (increased heart rate, higher frequency EEG) or predominant cognitive-emotional hyperarousal (worry, rumination, repetitive thoughts). Strong evidence shows that those suffering from insomnia with physiological hyperarousal are at higher risk of short and long term severe health problems such as inflammation and hypertension than the group without physiological hyperarousal. The neurophysiological basis of these insomnia phenotypes has however barely been investigated, although its results can have major consequences for how this limiting condition will be treated. To support the development of a differential diagnosis of insomnia, structural and functional brain connectivity in insomnia patients with different levels of hyperarousal will be investigated and related to sleep variables. Investigators will compare the insomnia group to a normal sleeping control group. Investigators expect that the emotion processing circuit (amygdala-ventromedial prefrontal cortex) is a) more affected in insomniacs compared to normal sleeping controls and b) the directionality of this effect to depend on the level and type of hyperarousal in insomniacs. Further, investigators expect c) amygdala activity to be positive correlated with physiological hyperarousal level and d) prefrontal activity to be positively correlated with cognitive-emotional hyperarousal level. Investigators expect a higher physiological hyperarousal level to be reflected in affected afferent pathways of the amygdala towards the ventromedial prefrontal cortex and investigators expect higher cognitive-emotional hyperarousal to be related to affected efferent pathways from the ventromedial prefrontal cortex to the amygdala. Investigators expect sleep quality to play a mediating role in both types of hyperarousal and their brain activation patterns in insomnia patients and normal sleeping controls. These data can lead to the definition of new insomnia phenotypes and to new customized and effective insomnia treatment, focused not only on improving sleep but also on changing dysfunctional hyperarousal levels that currently put insomniacs at risk of numerous severe health problems.

Interventions

OTHERMRI

Sponsors

Institut des Maladies Neurodégénératives (UMR5293)
CollaboratorUNKNOWN
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Insomnia group: patients with insomnia: sleep complaints, of at least 3 nights a week, for at least 3 months, affected daytime functioning. * control group: no self-reported sleep problems in the last 2 months. * 20-50 years old. * Male or female. * having given written informed consent to participate in the research project.

Exclusion criteria

* Night and shift-workers. * Psychiatric disorder: clinical mood disorder, anxiety disorder, psychosis, bipolar disorder. * For insomnia group: all sleep disorders other than persistent insomnia. * For control group: all sleep disorders. * Progressive neurological diseases that include restless legs syndrome. * Cardiovascular disease other than treated hypertension. * Unstable respiratory or endocrinological diseases. * Drug addiction, alcohol addiction during the previous 6 months. * Having undertaken trans-meridian travel (± 3H) in the previous 1 month. * Pregnant or lactating women. * Chronic pain. * Hypnotic and psychotropic medication taking or stopped less than 5 half-life periods of molecules before screening V0. * Patient participating to any other interventional study. * For MRI: presence of a ferromagnetic foreign body (in particular certain intracranial clips, certain cardiac valves, intraocular foreign body, or subject having worked with metals), the presence of an implanted pacemaker, subject with cardiac or brain valves of ventricular derivation (risk of maladjustment), claustrophobia.

Design outcomes

Primary

MeasureTime frame
Resting state intrinsic connectivity within the emotion processing network by MRIDuring Visit V2 (study termination), up to 3 month after consent signature

Secondary

MeasureTime frame
Sleep efficiency obtained by actimetryDuring the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Wake after sleep onset obtained by actimetryDuring the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep latency obtained by actimetryDuring the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Total sleep time obtained by sleep diaryDuring the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep efficiency obtained by sleep diaryDuring the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Wake after sleep onset obtained by sleep diaryDuring the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
sleep latency obtained by sleep diaryDuring the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Total sleep time obtained by actimetryDuring the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Questionnaire regarding sleep problems : Insomnia Severity Index (ISI)During Pre-inclusion Visit, at consent signature
Questionnaire regarding depression : Beck Depression Inventory (BDI)During Pre-inclusion Visit, at consent signature
Questionnaire regarding anxiety : Beck Anxiety Inventory (BAI)During Pre-inclusion Visit, at consent signature
Questionnaire regarding arousal : Arousal Predisposition Scale (APS)During Inclusion Visit, up to 1 month after consent signature
Questionnaire regarding sleep reactivity : Ford Insomnia Response to Stress Test (FIRST)During Inclusion Visit, up to 1 month after consent signature
Questionnaire regarding presleep arousal state : Presleep State Arousal Scale (PSAS)During Visit V2 (study termination), up to 3 month after consent signature
Questionaire regarding emotional state : Positive and Negative Affect Schedule (PANAS)During Visit V2 (study termination), up to 3 month after consent signature
Questionnaire regarding sleep problems : Pittsburgh Sleep Questionaire (PSQ)During Pre-inclusion Visit, at consent signature

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026