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

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ClinicalTrials.gov Identifier: NCT02821234
Recruitment Status : Completed
First Posted : July 1, 2016
Last Update Posted : August 23, 2017
Sponsor:
Collaborator:
Institut des Maladies Neurodégénératives (UMR5293)
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Insomnia Other: MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Sleepless Brain: Neuroimaging Support for a Differential Diagnosis of Insomnia
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : April 3, 2017
Actual Study Completion Date : April 3, 2017

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
Other: MRI
Experimental: Control group
Volunteer without sleep problems either self-reported or objectified through actigraphy (SE ≥85%)
Other: MRI



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Total sleep time obtained by actimetry [ Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature) ]
  2. Sleep efficiency obtained by actimetry [ Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature) ]
  3. Wake after sleep onset obtained by actimetry [ Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature) ]
  4. Sleep latency obtained by actimetry [ Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature) ]
  5. Total sleep time obtained by sleep diary [ Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature) ]
  6. Sleep efficiency obtained by sleep diary [ Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature) ]
  7. Wake after sleep onset obtained by sleep diary [ Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature) ]
  8. sleep latency obtained by sleep diary [ Time Frame: During the 10 nights preceding Inclusion Visit (up to 1 month after consent signature) ]
  9. Questionnaire regarding sleep problems : Pittsburgh Sleep Questionaire (PSQ) [ Time Frame: During Pre-inclusion Visit, at consent signature ]
  10. Questionnaire regarding sleep problems : Insomnia Severity Index (ISI) [ Time Frame: During Pre-inclusion Visit, at consent signature ]
  11. Questionnaire regarding depression : Beck Depression Inventory (BDI) [ Time Frame: During Pre-inclusion Visit, at consent signature ]
  12. Questionnaire regarding anxiety : Beck Anxiety Inventory (BAI) [ Time Frame: During Pre-inclusion Visit, at consent signature ]
  13. Questionnaire regarding arousal : Arousal Predisposition Scale (APS) [ Time Frame: During Inclusion Visit, up to 1 month after consent signature ]
  14. Questionnaire regarding sleep reactivity : Ford Insomnia Response to Stress Test (FIRST) [ Time Frame: During Inclusion Visit, up to 1 month after consent signature ]
  15. Questionnaire regarding presleep arousal state : Presleep State Arousal Scale (PSAS) [ Time Frame: During Visit V2 (study termination), up to 3 month after consent signature ]
  16. Questionaire regarding emotional state : Positive and Negative Affect Schedule (PANAS) [ Time Frame: During Visit V2 (study termination), up to 3 month after consent signature ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821234


Locations
France
CHU de Bordeaux
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Institut des Maladies Neurodégénératives (UMR5293)

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02821234     History of Changes
Other Study ID Numbers: CHUBX 2016/05
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Bordeaux:
Insomnia
Hyperarousal

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders