- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821234
The Sleepless Brain: Neuroimaging Support for a Differential Diagnosis of Insomnia (SOMNET)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bordeaux, France, 33000
- CHU de Bordeaux
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Insomnia group
Patients with insomnia: sleep complaints, of at least 3 nights a week, for at least 3 months, affected daytime functioning, objectified low sleep quality (SE <85%) with 10 days actigraphy occurred in the last 2 months
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EXPERIMENTAL: Control group
Volunteer without sleep problems either self-reported or objectified through actigraphy (SE ≥85%)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resting state intrinsic connectivity within the emotion processing network by MRI
Time Frame: During Visit V2 (study termination), up to 3 month after consent signature
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During Visit V2 (study termination), up to 3 month after consent signature
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total sleep time obtained by actimetry
Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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Sleep efficiency obtained by actimetry
Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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Wake after sleep onset obtained by actimetry
Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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Sleep latency obtained by actimetry
Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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Total sleep time obtained by sleep diary
Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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Sleep efficiency obtained by sleep diary
Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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Wake after sleep onset obtained by sleep diary
Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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sleep latency obtained by sleep diary
Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
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Questionnaire regarding sleep problems : Pittsburgh Sleep Questionaire (PSQ)
Time Frame: During Pre-inclusion Visit, at consent signature
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During Pre-inclusion Visit, at consent signature
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Questionnaire regarding sleep problems : Insomnia Severity Index (ISI)
Time Frame: During Pre-inclusion Visit, at consent signature
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During Pre-inclusion Visit, at consent signature
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Questionnaire regarding depression : Beck Depression Inventory (BDI)
Time Frame: During Pre-inclusion Visit, at consent signature
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During Pre-inclusion Visit, at consent signature
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Questionnaire regarding anxiety : Beck Anxiety Inventory (BAI)
Time Frame: During Pre-inclusion Visit, at consent signature
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During Pre-inclusion Visit, at consent signature
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Questionnaire regarding arousal : Arousal Predisposition Scale (APS)
Time Frame: During Inclusion Visit, up to 1 month after consent signature
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During Inclusion Visit, up to 1 month after consent signature
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Questionnaire regarding sleep reactivity : Ford Insomnia Response to Stress Test (FIRST)
Time Frame: During Inclusion Visit, up to 1 month after consent signature
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During Inclusion Visit, up to 1 month after consent signature
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Questionnaire regarding presleep arousal state : Presleep State Arousal Scale (PSAS)
Time Frame: During Visit V2 (study termination), up to 3 month after consent signature
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During Visit V2 (study termination), up to 3 month after consent signature
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Questionaire regarding emotional state : Positive and Negative Affect Schedule (PANAS)
Time Frame: During Visit V2 (study termination), up to 3 month after consent signature
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During Visit V2 (study termination), up to 3 month after consent signature
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2016/05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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