An interventional study of MRI in Insomnia, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Basic science
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.
1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's enrollment of 40 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.
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Exclusion Criteria:
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
Other: MRI
Volunteer without sleep problems either self-reported or objectified through actigraphy (SE ≥85%)
Other: MRI
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
Total sleep time obtained by actimetry
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep efficiency obtained by actimetry
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Wake after sleep onset obtained by actimetry
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep latency obtained by actimetry
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Total sleep time obtained by sleep diary
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Sleep efficiency obtained by sleep diary
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Wake after sleep onset obtained by sleep diary
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
sleep latency obtained by sleep diary
Time frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature)
Questionnaire regarding sleep problems : Pittsburgh Sleep Questionaire (PSQ)
Time frame: During Pre-inclusion Visit, at consent signature
Questionnaire regarding sleep problems : Insomnia Severity Index (ISI)
Time frame: During Pre-inclusion Visit, at consent signature
Questionnaire regarding depression : Beck Depression Inventory (BDI)
Time frame: During Pre-inclusion Visit, at consent signature
Questionnaire regarding anxiety : Beck Anxiety Inventory (BAI)
Time frame: During Pre-inclusion Visit, at consent signature
Questionnaire regarding arousal : Arousal Predisposition Scale (APS)
Time frame: During Inclusion Visit, up to 1 month after consent signature
Questionnaire regarding sleep reactivity : Ford Insomnia Response to Stress Test (FIRST)
Time frame: During Inclusion Visit, up to 1 month after consent signature
Questionnaire regarding presleep arousal state : Presleep State Arousal Scale (PSAS)
Time frame: During Visit V2 (study termination), up to 3 month after consent signature
Questionaire regarding emotional state : Positive and Negative Affect Schedule (PANAS)
Time frame: During Visit V2 (study termination), up to 3 month after consent signature
Plan to share: No
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
University Hospital, Bordeaux