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TIP: Investigating Racing Thoughts in Patients With Insomnia Disorder

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04752254
Collaborator
(none)
150
Enrollment
1
Location
14
Anticipated Duration (Months)
10.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Cognitive arousal has been identified as playing a key role in the inability to fall asleep or stay asleep. However, although people with insomnia frequently complain about racing thoughts appearing as soon as they get into bed, studies focusing on racing thoughts in insomnia are lacking. The aim of the present study is to investigate racing thoughts in insomnia disorder using a self-report questionnaire, the Racing and Crowded Thoughts Questionnaire. Specifically, the researchers seek to address three related goals: the comparison of RCTQ scores in adults with primary insomnia, healthy individuals, and patients with bipolar disorder in a manic/hypomanic episode; the variation of RCTQ scores relative to time of day; and the specific contribution of racing thoughts to insomnia severity, as compared to worry and rumination.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Cognitive Hyperarousal in Insomnia Disorder
    Actual Study Start Date :
    Oct 1, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2021
    Anticipated Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. A retrospective evaluation of self-reported tachypsychia in primary insomnia [Files analysed retrospectively from Jun 01, 2014 to March 13, 2020 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 78 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Major subject from 18 to 70 years old)

    • with a diagnosis of chronic primary insomnia according to the criteria of ICSD-3

    • Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research

    Exclusion Criteria:

    • Subject having expressed opposition to participating in the study

    • Subject under guardianship or guardianship

    • Subject under safeguard of justice

    • Patient with secondary insomnia (OSA, circadian rhythm disorder, severe restless legs syndrome, bipolar disorder, ADD +/- H)

    • Subject under psychotropic treatment other than hypnotics

    • Incomplete data concerning the main endpoint

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Sleep Disorders - CIRCSom - Strasbourg University Hospitals Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT04752254
    Other Study ID Numbers:
    • 7987
    First Posted:
    Feb 12, 2021
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Insomnia
    Hyperarousal
    Rumination
    Racing thoughts
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders

    Study Results

    No Results Posted as of Oct 13, 2021