Insomnia Disorder Clinical Trial
— TIPOfficial title:
Cognitive Hyperarousal in Insomnia Disorder
NCT number | NCT04752254 |
Other study ID # | 7987 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2020 |
Est. completion date | August 31, 2023 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 78 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Center for Sleep Disorders - CIRCSom - Strasbourg University Hospitals | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A retrospective evaluation of self-reported tachypsychia in primary insomnia | Files analysed retrospectively from Jun 01, 2014 to March 13, 2020 will be examined] |
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